What a retrace eh? Watching for this to drop a bit more since it still isn't getting the volume attention. Low volumes and a few warrants and convertibles.
BTW – there are only a couple boards talking about this (and I’m keeping my posts for this one here) so if things start heating up remember where you heard it! LOL.
a little info...
Overview
Neurologix, Inc., a leader in the development of innovative therapies for the brain and central nervous system, utilizes gene therapy and other novel technologies. The central nervous system ("CNS") is a new and particularly exciting target for gene therapy because its unique properties prevent the successful treatment of many neurological disorders by conventional means such as drug therapy and surgery. The Company has developed numerous technologies designed to deliver gene therapy as a treatment for CNS disorders.Gene therapy works by intervening and altering the instruction set of a cell in order to either compensate for a missing or ineffective gene or provide an entirely new property to specific cells. The Company's first-generation proprietary gene transfer technology platform ('NLX') was approved by the FDA for Phase I clinical trials for the treatment of 12 patients with Parkinson's disease. All patients have undergone surgical gene therapy at The New York Presbyterian Hospital/Weill Medical College of Cornell University and have been followed with both neurological evaluations and PET scans of the brain at North Shore University Hospital. The basis of the Company's gene transfer technology is its proprietary ability to utilize specific vectors along with cell promoters in order to (1) target specific cells (those requiring new instruction), (2) effectively transduce the cell or deliver the gene, and (3) show stable and persistent expression (i.e., therapy that works consistently for a period of time). The Company's first-generation gene transfer technology uses an adeno-associated virus ("AAV") vector as the delivery mechanism for the cells. The use of viral vectors takes advantage of the natural efficiency with which viruses deliver genes to cells. Future-generation gene transfer technology may utilize other vectors as well as a proprietary promoter (enabler) technology for the long-term and regulatable expression necessary for gene transfer and function. In addition, the Company has other novel technologies in development for the treatment of Parkinson's Disease ("PD"), epilepsy, and other CNS related disorders.
At May 11, 2007 there were outstanding 26,542,924 shares of the Registrant's Common Stock, $.001 par value. 60mm authorized.
Treatment Phase Details Click on Phase Number for DETAILED INFORMATION on that phase
Phase Status Title of Trial Start Date Duration Weeks Sponsor
Preclinical Phase Completed Unknown Neurologix, Inc. (USA)
Phase 1 Phase Completed Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease 8/18/2003 48 Neurologix, Inc. (USA)
Phase 2 Not Started Glutamic Acid Decarboxylase (GAD) Gene Therapy, Phase 2 Fourth Quarter, 2007 52 weeks Neurologix, Inc. (USA)
Phase 3 Not Started Neurologix, Inc. (USA)
Phase 4 Not Started Neurologix, Inc. (USA) -------------
Obviously we have plenty of time to go through this pretty thoroughly. There are some deep pockets funding this. This is NOT A BUY recommendation, if anything a "wait". The last run was premature (and purdy!) but not enough to hold it up. I think it may fall a bit more. Do your own DD. Still about 1 year to go to get through phase II but it has some good eyes on it imo.
Here are some things to consider that I found a very interesting read when looking into a biotech. IMO you can apply this to other sectors as well but this read is mainly for biotech…
NEWS IN CONTEXT: Phase 1 Safety Trial of Novel Gene Therapy for PD Reported Safe and Tolerable
On Friday, June 22, news outlets reported the publication in the journal Lancet of results from a Phase 1 trial conducted to determine the safety of a novel gene therapy approach to Parkinson’s. The trial, conducted in 12 patients, determined that the approach was safe, and researchers also reported that it seemed to improve PD symptoms without causing side effects.
The Michael J. Fox Foundation spoke to Thomas Wichmann, MD, associate professor of neurology at Emory University in Atlanta, Georgia, about how people with Parkinson’s should interpret the news.
Posted by BooDog on :
NEUROLOGIX INC (OTC BB:NRGX.OB)
Last Trade: 1.25 Trade Time: 2:43PM ET Change: 0.08 (6.84%) Prev Close: 1.17 Open: 1.19 Bid: 1.16 x 500 Ask: 1.25 x 500 1y Target Est: N/A
9mm cash on hand expenses are about 500k / qtr
Posted by BooDog on :
08/13/07 2:43 p.m. ET Neurologix NRGX.OB (Common Stock) Exchange: OTC BB (US Dollar) Price $1.25 Change + 0.08 % Change 6.84% Today's Open $1.19 Intraday High $1.25 Previous Close $1.17 Intraday Low $1.19 52 Week High $2.15 Bid $1.16 52 Week Low $0.45 Ask $1.25 Market Cap $33,178,750 Shares Outstanding 26,543,000 Volume 5,500
Posted by BooDog on :
Top Holders Shares Held % O/S Share Change Filing Date Palisade Capital Management L.L.C. 6,813,690 25.7 0 06/30/07 ATEC Trust 3,387,608 12.8 -75,000 04/02/07 Kaplitt (Martin J) 2,413,001 9.1 0 04/02/07 Medtronic Inc. 2,321,559 8.8 0 04/02/07 Johnson (Clark A) 575,508 2.2 125,000 04/02/07 Ursus Capital Management L.L.C. 385,000 1.5 0 12/31/05 Meyer Handelman Company 64,000 0.2 0 06/30/07 Singer (Elliott H) 40,000 0.2 15,000 04/02/07 Mordock (John E) 20,000 0.1 20,000 04/02/07 Nickels (Craig J) 20,000 0.1 20,000 04/02/07
Posted by BooDog on :
should touch back on the 200 around .91 thinking in the next couple weeks. Looking for .85.
Posted by BooDog on :
took a bit longer than I thought to get close to .85 almost there and now I'm looking for .75. -----------
On October 1, 2007, Neurologix, Inc. (the “Company”) entered into a letter agreement
(the “Letter Agreement”) dated October 1, 2007 with Dr. Matthew During. The Letter Agreement amends a Consulting Agreement dated October 1, 1999, as amended (the “Consulting Agreement”), by and between the Company and Dr. During. The Letter Agreement extends the term of the Consulting Agreement from September 30, 2007, to September 30, 2008. Dr. During is a co-founder of the Company and a member of its Scientific Advisory Board.
Matthew J. During, M.D., DSc.
Dr. During is an internationally recognized leader in the fields of gene therapy of neurological diseases and human brain microdialysis, areas in which he is a world pioneer. He is currently Professor of Molecular Medicine and Pathology at University of Auckland in New Zealand and Director of the Molecular and Translational Neuroscience Laboratory, Department of Neurological Surgery, Weill Medical College of Cornell University. He also served as Director of the CNS Gene Therapy Center and Professor of Neurosurgery at Jefferson Medical College from 1998 through 2002. At the University of Auckland, Dr. During directs major neuroscience and gene therapy programs. One of his most recent and important accomplishments in gene therapy field was completion of the first non-cancer CNS gene therapy trial, a subject of major articles in publications such as Science. In addition, Dr. During made a significant breakthrough in the development of a novel vaccine for stroke and epilepsy (again published in Science) as well as a novel oral gene delivery method for diseases like diabetes.
In addition to research and teaching, Dr. During has authored more than 100 groundbreaking papers in the fields of neuroscience, molecular biology, gene transfer and therapy, including many articles in such prestigious journals as Nature, Science, Nature Genetics and Nature Medicine.
Dr. During is a graduate of University of Auckland School of Medicine, and did further postgraduate training at M.I.T. (1985 - 1987), Harvard Medical School (1986 - 1989) and at Yale (1988 - 1989). He was on the Faculty at Yale University from 1989 through 1998, where he directed a program on the molecular basis of learning and memory, and headed Yale's first gene therapy protocol.
o/s as of 4 Oct 26,812,378 At May 11, 2007 there were outstanding 26,542,924
Posted by 10of13 on :
Bump...
Posted by BooDog on :
quote:Originally posted by 10of13: Bump...
Cheers 10!! Posted by BooDog on :
Stockholders' equity: Preferred stock; 5,000,000 shares authorized: Series A - Convertible, $0.10 par value; 650 shares designated, 645 shares issued and outstanding with an aggregate liquidation preference of $645 - Series C - Convertible, $0.10 par value; 700,000 shares designated, 418,769 shares issued and outstanding with an aggregate liquidation preference of $13,562,978
Common Stock: $0.001 par value; 100,000,000 shares authorized, 26,892,976 issued and outstanding at September 30,
...."The Company had cash, cash equivalents and short-term investments of approximately $6.3 million at September 30, 2007, which management believes will be sufficient to fund the Company's operations through March 31, 2008."
....""Financial performance for the quarter is in line with our expectations," said John Mordock, President and Chief Executive Officer of Neurologix. "Subject to regulatory authorization, we are ready to begin a Phase 2 study of our gene therapy procedure for the treatment of Parkinson's disease. We have the only non-dopamine centered gene therapy for Parkinson's disease currently in development. The results of our initial Phase 1 study with this approach demonstrated both an excellent safety profile and statistically significant improvements in clinical symptoms and brain metabolism in patients with advanced disease. We believe our gene transfer approach may further offer a gateway to other innovative therapies for a variety of central nervous system disorders, and we will begin a Phase 1 safety study in epilepsy as soon as we receive authorization from the FDA."
Ability of Neurologix's Gene Transfer Therapy to Quiet Abnormal Brain Activity in Parkinson's Disease Patients Reported in PNAS Monday November 19, 5:01 pm ET Reductions in Biomarker Correlate to Clinical Benefit; Provide Quantifiable, Non-Subjective Measurement of Efficacy
FORT LEE, N.J.--(BUSINESS WIRE)--New data from the first-ever clinical trial of a novel gene therapy for advanced Parkinson’s disease demonstrate the ability of Neurologix, Inc.’s (OTCBB:NRGX - News) gene transfer treatment to quiet the abnormal brain activity that is correlated with the motor deficits characterizing the disease. Details regarding the normalization of brain activity in treated patients, as measured through radiolabeled glucose uptake and positron emission tomography (PET), were published this week in the online edition of the Proceedings of the National Academy of Sciences. “In recent years we have been able to identify highly specific patterns of abnormal metabolic activity in patients with Parkinson’s disease. These patterns can be quantified with high reliability using PET imaging,” said David Eidelberg, M.D., Director of the Center for Neurosciences at The Feinstein Institute for Medical Research, and senior author of the new publication. “In particular, the brain network associated with abnormal motor function demonstrates increasingly higher levels of activity as Parkinson’s disease progresses. Existing treatments for Parkinson’s symptoms including drug therapies and deep brain stimulation are known to suppress this abnormal brain network.”
“In this publication,” Dr. Eidelberg continued, “we report that the previously published safety and tolerability seen in the Phase 1 open label study of Neurologix’s Parkinson’s disease treatment was also associated with a significant reduction in abnormal network activity in patients receiving the experimental treatment. Moreover, the degree of reduction in this biomarker correlated with the clinical benefit that the treated patients experienced.”
In the Phase 1 study, the investigators injected an adeno-associated virus (AAV) vector carrying an inhibitory gene (glutamic acid decarboxylase or “GAD”) into one side of the subthalmic nucleus (STN) of the brain of 12 patients with advanced Parkinson’s disease. The GAD gene was intended to increase the synthesis of the major inhibitory neurotransmitter in the brain, gamma-aminobutyric acid, or “GABA”, and thus calm the overactive STN. Although all patients had symptoms on both sides of their bodies, the gene transfer procedure was performed on only one side of the brain, enabling the untreated side to serve as a study control. Improvements in both clinical symptoms and abnormal brain network activity were seen predominately on the treated side of the brain at six months following treatment. Both the clinical benefit and the metabolic improvement persisted through the 12 months of the study period. Moreover, the improvements in brain metabolism occurred in areas of the motor network different from those known to be produced by brain lesioning alone. At the same time, the activity of the cognition-related brain network did not change following the gene transfer procedure.
“We are very encouraged by these findings,” said John Mordock, Neurologix President and Chief Executive Officer. “They clearly support the previously reported results from this study, published earlier this year in The Lancet. Moreover, they also suggest a highly useful, measurable biomarker of efficacy for use in subsequent studies of our gene transfer approach to the treatment of Parkinson’s disease and potentially other neurodegenerative conditions. We expect to begin a Phase 2 study of our approach in Parkinson’s disease within the coming weeks, and believe that we are on track to begin a Phase 1 study in epilepsy.”
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson’s disease, epilepsy and Huntington’s chorea, all of which are large markets not adequately served by current therapeutic options.
This news release includes certain statements of the Company that may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words “expects,” “promises,” “anticipates,” “estimates,” “plans,” “intends,” “projects,” “predicts,” “believes,” “may” or “should,” and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company’s management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is still in the development stage and has not generated any revenues. From inception through September 30, 2007, it incurred net losses and negative cash flows from operating activities of approximately $26.2 million and $20.3 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability. The Company will need to conduct future clinical trials for treatment of Parkinson’s disease using the Company’s NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed. There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase I safety trial for the treatment of epilepsy. Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management’s expectations is found in the section entitled “Risk Factors” in the Company’s 2006 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company’s expectations.
Contact: Neurologix, Inc. Marc Panoff, CFO, 201-592-6451 or Kureczka/Martin Associates Ellen M Martin, 510-832-2044 emm4*pacbell.net
Posted by BooDog on :
Check this out...
By NIDHI THAREJA, M.D. ABC News Medical Unit Nov. 20, 2007 Font Size
E-mail Print Share Scientists have imbued ordinary human skin cells with the versatile qualities of embryonic stem cells -- what some doctors call a scientific breakthrough that could change the tone of the ongoing stem cell research debate.
The advance was published in two independent studies reported in the journals Cell and Science on Tuesday. Possible Breakthrough in Stem Cell... Scientists found a way to mimic embryonic stem cells without using embryos. 11/20/2007 http://abcnews.go.com/Health/story?id=3891547&page=1
The findings on the technique, known as "direct reprogramming," follow a study published last week in the journal Nature that reported the extraction of stem cells from cloned monkey embryos, which contained genetic material from adult monkey skin cells. And they come five months after a similar feat was accomplished in mice.
The technique has big implications for human stem cell research, as it sidesteps many of the ethical and political pitfalls that have dogged the field for years.
Now that the research has been done in human cells, the excitement in the stem cell community is mounting. And while it may not be the perfect solution, many say it's a major advance.
"The discovery that it is possible to reprogram adult human cells to pluripotency using a simple combination of genes is an important breakthrough," said Sean Morrison, director of the stem cell biology research center at University of Michigan, Ann Arbor.
"It represents a phenomenal breakthrough, more important than cloning … or the discovery of human embryonic stem cells," said Dr. Markus Grompe, director of the Oregon Stem Cell Center in Portland. "This is a Nobel Prize worthy advance."
Researchers led by Shinya Yamanaka at the Kyoto University in Kyoto, Japan, generated cells called "induced pluripotent stem cells" by inducing four different genes to hitch a ride into human skin cells within specially designed viruses. These genes incorporated themselves into the skin cells, transforming them.
The new cells displayed several characteristics of embryonic stem cells, including the ability to grow into nerve and heart cells.
Posted by BooDog on :
Back to Main
November 20, 2007
Researchers Create Stem Cells Without Destroying Embryos
By Gauatam Naik, Wall Street Journal
In the quest to treat difficult diseases, researchers have created human embryonic stem cells without destroying embryos or using hard-to-get eggs. The technique may prove to be easier, cheaper, and more ethically appealing than an alternative approach that requires cloning.
Two separate teams of researchers say they have sidestepped the cloning method and reprogrammed mature human cells into a primordial, embryonic-like state. Those cells were then transformed into other tissue types, such as heart cells. The long-term hope is that such freshly-created tissue may, for example, be used to heal a heart-attack patient.
Unlike cloning, "the wonderful thing about this approach is that it's easy. You're going to see lots and lots of labs give it a try," predicts Robert Blelloch, a stem cell biologist at the University of California, San Francisco, who has performed his own reprogramming experiments. He says he read the latest studies but wasn't involved in them.
One set of experiments, published today in the journal Cell, was led by Shinya Yamanaka of Kyoto University. A second paper was published in Science by researchers at the lab of James Thomson of the University of Wisconsin, who created the first human stem-cell line in 1998.
The Science and Cell papers were embargoed for general release until noon, New York time, but an Australian paper broke the embargo.
In both experiments, the scientists inserted several genes into a mature human cell. For reasons that no one can yet fully explain, this essentially reset the molecular clock and turned older, mature cells into embryonic-like cells.
There are several limitations to the current approach. For now, both teams had to use dangerous viruses to effectively transport the genes into the cell, which could have deadly consequences if it was immediately applied to humans. Dr. Yamanaka and others say they are testing other viruses in the hopes of finding a non-harmful one.
And before the reprogramming technique can be applied to human patients, it needs to be tested on large animal models to ensure that it's safe and effective.
Still, the latest results are a big step up from similar breakthroughs in mice, separately reported this summer by Dr. Yamanaka's group and two other research teams in the U.S. The Kyoto team reported that embryonic-like cells developed with the new technique could even help form a new mouse -- a gold-standard test for the viability of the created tissue.
Almost nobody predicted that the same feat could be repeated with human cells quite so quickly.
"We were very surprised because human and mouse embryonic cells are very different," says Dr. Yamanaka, who is also a senior investigator at the Gladstone Institute of Cardiovascular Disease in San Francisco, and is rapidly emerging as the leading scientist in his field. Much of the reprogramming experiments published this summer was sparked by a landmark paper he published in 2006.
Many scientists have believed that stem cells' grand promise would more likely be fulfilled if they created an embryonic clone of a patient, and then harvested that clone for fresh tissue. Heart, nerve or other cells obtained that way would have a singular advantage: They wouldn't trigger an immune response from patient because they'd share the same DNA.
There aren't any sizable ethical concerns or immune-response worries with reprogramming. But to many, the science seems daunting, even implausible.
"You have this extremely strong arrow of time -- and it's is going completely backwards," says Dr. Thomson. His team, including researcher Junying Yu, also used four genes to reprogram the human cell. Two of the genes they used were different from the ones tested by their counterparts in Japan.
Despite the latest breakthroughs, the nuclear transfer approach – which uses a cloning step to get embryonic stem cells – isn't likely to disappear. Just last week, for example, researchers in Oregon created embryonic clones of monkeys, suggesting that the nuclear-transfer method still hold considerable promise.
However, nuclear-transfer is being held back by several problems. It's hard to get human eggs; the technology is expensive and tricky; and funding isn't so readily available. A major scandal has hurt, too. In 2005, a Korean researcher published a study that appeared to show that he had created human-embryonic clones, but the claim turned out to be fraudulent.
So it's not such a surprise that Ian Wilmut, the man who cloned Dolly the sheep a decade ago, recently said he has been persuaded to give up his own cloning experiments, thanks to news of Dr. Yamanaka's successes.
"Any scientist with basic technology in molecular and cell biology can do reprogramming," says Dr. Yamanaka. "If we can overcome the issue [of having to use dangerous viruses to ferry the genes into cells], many more people will move from nuclear transfer to this method."
While this news is great for those deep into stem cell research the benefit of this will imo be realized much quicker in gene therapy. This is a major step forward for this entire sector.
'Milestone' stem cell advance reportedStory Highlights Scientists: Embryonic stem cell equivalents created from adult human skin cells
Avoids ethical, political, practical obstacles of cloning embryos to make stem cells
Expert: "Tremendous scientific milestone"; likened to Wright Brothers' first plane
Technique creates cancer risk; scientists say it can be avoided in the future
Next Article in Health »
Read VIDEO
NEW YORK (AP) -- Scientists have made ordinary human skin cells take on the chameleon-like powers of embryonic stem cells, a startling breakthrough that might someday deliver the medical payoffs of embryo cloning without the controversy.
One of the breakthrough teams works in the lab of James Thomson, here with lab manager Jessica Antosiewicz.
Laboratory teams on two continents report success in a pair of landmark papers released Tuesday. It's a neck-and-neck finish to a race that made headlines five months ago, when scientists announced that the feat had been accomplished in mice.
The "direct reprogramming" technique avoids the swarm of ethical, political and practical obstacles that have stymied attempts to produce human stem cells by cloning embryos.
Scientists familiar with the work said scientific questions remain and that it's still important to pursue the cloning strategy, but that the new work is a major coup.
"This work represents a tremendous scientific milestone -- the biological equivalent of the Wright Brothers' first airplane," said Dr. Robert Lanza, chief science officer of Advanced Cell Technology, which has been trying to extract stem cells from cloned human embryos.
"It's a bit like learning how to turn lead into gold," said Lanza, while cautioning that the work is far from providing medical payoffs. CNN's Elizabeth Cohen explains the stem cell breakthrough »
"It's a huge deal," agreed Rudolf Jaenisch, a prominent stem cell scientist at the Whitehead Institute in Cambridge, Massachusetts. "You have the proof of principle that you can do it."
The White House lauded the papers, saying such research is what President Bush was advocating when he twice vetoed legislation to pave the way for taxpayer-funded embryo research.
There is a catch. At this point, the technique requires disrupting the DNA of the skin cells, which creates the potential for developing cancer. So it would be unacceptable for the most touted use of embryonic cells: creating transplant tissue that in theory could be used to treat diseases like diabetes, Parkinson's, and spinal cord injury.
But the DNA disruption is just a byproduct of the technique, and experts said they believe it can be avoided.
Two teams, two journals
The new work is being published online by two journals, Cell and Science. The Cell paper is from a team led by Dr. Shinya Yamanaka of Kyoto University; the Science paper is from a team led by Junying Yu, working in the lab of in stem-cell pioneer James Thomson of the University of Wisconsin-Madison.
Both reported creating cells that behaved like stem cells in a series of lab tests.
Thomson, 48, made headlines in 1998 when he announced that his team had isolated human embryonic stem cells.
Yamanaka gained scientific notice in 2006 by reporting that direct reprogramming in mice had produced cells resembling embryonic stem cells, although with significant differences. In June, his group and two others announced they'd created mouse cells that were virtually indistinguishable from stem cells.
Don't Miss TIME.com: 'I think this is the future of stem cell research' For the new work, the two men chose different cell types from a tissue supplier. Yamanaka reprogrammed skin cells from the face of an unidentified 36-year-old woman, and Thomson's team worked with foreskin cells from a newborn. Thomson, who was working his way from embryonic to fetal to adult cells, said he's still analyzing his results with adult cells.
Both labs did basically the same thing. Each used viruses to ferry four genes into the skin cells. These particular genes were known to turn other genes on and off, but just how they produced cells that mimic embryonic stem cells is a mystery.
"People didn't know it would be this easy," Thomson said. "Thousands of labs in the United States can do this, basically tomorrow."
The Wisconsin Alumni Research Foundation, which holds three patents for Thomson's work, is applying for patents involving his new research, a spokeswoman said. Two of the four genes he used were different from Yamanaka's recipe.
Scientists prize embryonic stem cells because they can turn into virtually any kind of cell in the body. The cloning approach -- which has worked so far only in mice and monkeys -- should be able to produce stem cells that genetically match the person who donates body cells for cloning.
That means tissue made from the cells should be transplantable into that person without fear of rejection. Scientists emphasize that any such payoff would be well in the future, and that the more immediate medical benefits would come from basic research in the lab.
Cloning expensive, difficult
In fact, many scientists say the cloning technique has proven too expensive and cumbersome in its current form to produce stem cells routinely for transplants.
The new work shows that the direct reprogramming technique can also produce versatile cells that are genetically matched to a person. But it avoids several problems that have bedeviled the cloning approach.
For one thing, it doesn't require a supply of unfertilized human eggs, which are hard to obtain for research and subjects the women donating them to a surgical procedure. Using eggs also raises the ethical questions of whether women should be paid for them.
In cloning, those eggs are used to make embryos from which stem cells are harvested. But that destroys the embryos, which has led to political opposition from President Bush, the Roman Catholic church and others.
Those were "show-stopping ethical problems," said Laurie Zoloth, director of Northwestern University's Center for Bioethics, Science and Society.
The new work, she said, "redefines the ethical terrain."
Richard Doerflinger, deputy director of pro-life activities for the U.S. Conference of Catholic Bishops, called the new work "a very significant breakthrough in finding morally unproblematic alternatives to cloning. ... I think this is something that would be readily acceptable to Catholics."
White House spokesman Tony Fratto said the new method does not cross what Bush considers an "ethical line." And Republican Sen. Tom Coburn of Oklahoma, a staunch opponent of publicly funded embryonic stem cell research, said it should nullify the debate.
Another advantage of direct reprogramming is that it would qualify for federal research funding, unlike projects that seek to extract stem cells from human embryos, noted Doug Melton, co-director of the Harvard Stem Cell Institute.
Still, scientific questions remain about the cells produced by direct reprogramming, called "iPS" cells. One is how the cells compare to embryonic stem cells in their behavior and potential. Yamanaka said his work detected differences in gene activity.
Your Health Tools MayoClinic.com: Stem Cell FAQs Healthology: Health Video Library If they're different, iPS cells might prove better for some scientific uses and cloned stem cells preferable for other uses. Scientists want to study the roots of genetic disease and screen potential drug treatments in their laboratories, for example.
Scottish researcher Ian Wilmut, famous for his role in cloning Dolly the sheep a decade ago, told London's Daily Telegraph that he is giving up the cloning approach to produce stem cells and plans to pursue direct reprogramming instead.
Other scientists said it's too early for the field to follow Wilmut's lead. Cloning embryos to produce stem cells remains too valuable as a research tool, Jaenisch said.
Dr. George Daley of the Harvard institute, who said his own lab has also achieved direct reprogramming of human cells, said it's not clear how long it will take to get around the cancer risk problem. Nor is it clear just how direct reprogramming works, or whether that approach mimics what happens in cloning, he noted.
So the cloning approach still has much to offer, he said.
Daley, who's president of the International Society for Stem Cell Research, said his lab is pursuing both strategies.
"We'll see, ultimately, which one works and which one is more practical." E-mail to a friend
Posted by BooDog on :
up .09 low volume but nice itty bitty spike. lol
Posted by BooDog on :
News for 'NRGX' - (Neurologix Completes $15 Million Private Placement)
FORT LEE, N.J., Nov 26, 2007 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotech company engaged in the research and development of innovative gene therapies for the brain and central nervous system, announced today that it completed a private placement of $15 million of its newly created Series D Convertible Preferred Stock (the "Series D Stock") at a price of $35.00 per share. Each share of Series D Stock is convertible into approximately 30.17 shares of common stock.
The purchasers in the transaction include previous investor, General Electric Pension Trust, and new investor, Corriente Master Fund, LP. In addition, the Company issued warrants to purchase approximately 3,232,758 shares of its common stock at an exercise price of $1.39 per share. Holders of shares of the Company's Series C Preferred Stock (the "Series C Stock"), who participated in this transaction, had their shares automatically converted into shares of Series D Stock and additional shares of Series C Stock. The proceeds from the transaction, net of expenses, will be used to finance its Phase II clinical trial for the treatment of Parkinson's disease, its Phase I clinical trial for the treatment of epilepsy, and for corporate purposes.
"We are pleased that these elite financial institutions have chosen to invest in Neurologix as we advance the development of our novel gene transfer approach to the treatment of serious central nervous system disorders," said John Mordock, Neurologix President and Chief Executive Officer. "This is the latest in a series of important milestones the Company has achieved in 2007, which also included the publication of results from our Parkinson's disease Phase I clinical study in two leading peer-reviewed medical and scientific journals: The Lancet and Proceedings of the National Academy of Sciences. The proceeds of this financing will enable us to advance our acknowledged approach by supporting the completion of a Phase 2 study in the treatment of Parkinson's disease and a Phase 1 safety study in epilepsy."
Each share of outstanding Series D Stock is entitled to receive a semi-annual cash dividend at an annual rate of seven percent (7%), to be cumulative until paid. The purchasers, among other things, have registration rights and certain anti-dilution protections. The warrants have a term of seven years and are automatically exercised at the end of the term if they are in the money. Additional information regarding the transaction is included in the Company's Current Report on Form 8-K which was filed with the SEC on November 21, 2007.
Neither the securities issued in the transactions described above, nor the common stock issuable upon exercise or conversion of such securities, have been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state securities laws, and such securities may not be offered or sold in the United States without an effective registration statement or pursuant to an applicable exemption from the registration requirements of the Securities Act and state securities laws. The securities were offered and sold only to institutional accredited investors. This press release shall neither constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Neurologix
Neurologix, Inc. (OTCBB:NRGX) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is a development-stage company and has not generated any revenues. From inception through September 30, 2007, it incurred net losses and negative cash flows from operating activities of approximately $26.2 million and $20.3 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- In addition to the recently completed financing, in order to obtain the regulatory approvals necessary to commercialize its current or future product candidates, from time to time the Company will need to raise funds through public or private equity offerings, debt financings or additional corporate collaboration and licensing arrangements. Availability of financing depends upon a number of factors beyond the Company's control, including market conditions and interest rates. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase I safety trial for the treatment of epilepsy.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2006 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix, Inc.Marc Panoff, 201-592-6451Chief Financial Officer, Treasurer and Secretarymarcpanoff*neurologix.netorKureczka/Martin AssociatesJoan Kureczka, 415-821-2413jkureczka*comcast.net
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NEUROLOGIX INC (OTC BB:NRGX.OB)
Last Trade: 1.24 Trade Time: 1:50PM ET Change: 0.15 (13.76%) Prev Close: 1.09 Open: 1.15 Bid: 1.15 x 500 Ask: 1.24 x 500 1y Target Est: N/A
News for 'NRGX' - (DJ Corriente Advisors Reports 28.5% Neurologix Stake >NRGX) DOW JONES NEWSWIRES
Corriente Advisors LLC on Thursday reported holding a 28.5% stake in Neurologix Inc. (NRGX), according to a Schedule 13D filed with the Securities and Exchange Commission.
The Fort Worth, Texas-based investor beneficially owns about 10.78 million shares of Neurologix, a Fort Lee, N.J.-based biotech company.
Corriente said it acquired the shares for investment and believes they are "undervalued" and represent "an attractive investment opportunity."
Neurologix is engaged in the research and development of gene therapies for the brain and central nervous system.
The company's shares closed Wednesday at $1.10 each
-Brian Coyle, Dow Jones Newswires; 202-862-3545
(END) Dow Jones Newswires
November 29, 2007 06:55 ET (11:55 GMT)
Copyright (c) 2007 Dow Jones & Company, Inc.- - 06 55 AM EST 11-29-07
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yawn...
TGIF
Posted by BooDog on :
1.20 open. Get me excited fer nutin.
patience.......
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News for 'NRGX' - (Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research)
FORT LEE, N.J., Dec 04, 2007 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today the receipt of a grant from the Epilepsy Research Foundation (ERF), a unique joint venture of three non-profit epilepsy organizations -- the Epilepsy Therapy Project (ETP), Epilepsy Foundation (EF), and Finding a Cure for Epilepsy and Seizures (FACES) -- to identify and accelerate the development of promising epilepsy research. The grant will help fund a Phase I human clinical study of Neurologix's proprietary gene transfer approach to the treatment of epilepsy. The Company expects to initiate this study by early 2008, subject to final authorization from the United States Food and Drug Administration.
"We are very pleased to be chosen as a recipient of one of the ERF's research funding awards for promising approaches to the treatment of epilepsy," said John Mordock, President and Chief Executive Officer of Neurologix, Inc. "This award further recognizes the innovative nature of Neurologix's gene transfer approach to the treatment of epilepsy and the benefit it may offer for those affected with this serious brain disorder."
"More than 3 million people in the United States and 50 million people worldwide have some form of epilepsy, many of whom face persistent seizures despite the best available therapy," said Joyce Cramer, President of ETP. "We are very pleased to make this award to Neurologix as part of our effort to support the development of new therapies with the benefit to improve treatment and the quality of life for many with epilepsy."
Neurologix seeks to inhibit seizures caused by temporal lobe epilepsy and to reduce the invasiveness of current surgical treatment approaches by targeting a specific area within the brain, called the hippocampus, and delivering healthy genes where faulty or diminishing ones are causing the central nervous system disorder. In particular, Neurologix will seek to deliver the human Neuropeptide Y (NPY) gene, one of the brain's endogenous anticonvulsants, to neurons in the hippocampus where NPY will act on receptors to inhibit the brain over-activity that occurs during seizures. This approach builds on experience Neurologix has gained through its similar gene transfer approach to treating Parkinson's disease, where the company is preparing to begin Phase II human clinical trials.
About the Epilepsy Research Foundation
The Epilepsy Research Foundation was created to support the development of new, innovative translational research in producing new therapies and a cure for epilepsy. The organization was formed by the Epilepsy Therapy Project and the Epilepsy Foundation and includes support from Finding A Cure for Epilepsy and Seizures (FACES). All money raised goes directly toward highly promising research projects that can be fast tracked in the fight against seizures. For further information, or to contribute, please visit http://www.epilepsytdp.org,www.epilepsyfoundation.org, or contact the Epilepsy Research Foundation at 800-470-1655.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is a development-stage company and has not generated any revenues. From inception through September 30, 2007, it incurred net losses and negative cash flows from operating activities of approximately $26.2 million and $20.3 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- In addition to the recently completed financing, in order to obtain the regulatory approvals necessary to commercialize its current or future product candidates, from time to time the Company will need to raise funds through public or private equity offerings, debt financings or additional corporate collaboration and licensing arrangements. Availability of financing depends upon a number of factors beyond the Company's control, including market conditions and interest rates. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase I safety trial for the treatment of epilepsy.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2006 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix, Inc.Marc Panoff, 201-592-6451Chief Financial Officer, Treasurer and Secretarymarcpanoff*neurologix.netorKureczka/Martin AssociatesJoan Kureczka, 415-821-2413 (Media)jkureczka*comcast.net
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Interesting puzzle… NEUROLOGIX INC/DE Files SEC form 8-K, Change in Directors or Principal Officers, Financial Statements and Exhibits http://biz.yahoo.com/e/071204/nrgx.ob8-k.html
John E. Mordock, President and Chief Executive Officer On December 4, 2007, Neurologix, Inc. (the "Company") and John E. Mordock, the Company's President and Chief Executive Officer, entered into an employment agreement (the "Mordock Employment Agreement"). The Mordock Employment Agreement is more fully described on the Company's Current Report on Form 8-K that was filed with the Securities and Exchange Commission on September 20, 2007. The Mordock Employment Agreement is attached hereto as Exhibit 10.1 and incorporated by reference herein. Marc Panoff, Chief Financial Officer, Treasurer and Secretary On December 4, 2007, the Company and Marc Panoff, the Company's Chief Financial Officer, Treasurer and Secretary, entered into an employment agreement (the "Panoff Employment Agreement"). The Panoff Employment Agreement is more fully described on the Company's Current Report on Form 8-K that was filed with the Securities and Exchange Commission on September 20, 2007. The Panoff Employment Agreement is attached hereto as Exhibit 10.2 and incorporated by reference herein. -------------------------------------------------------- FORM 8-K September 20, 2007 http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=5444986&Ty pe=HTML
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Neurologix Completes $15 Million Private Placement Monday November 26, 8:55 am ET http://biz.yahoo.com/bw/071126/20071126005304.html?.v=1 …The proceeds from the transaction, net of expenses, will be used to finance its Phase II clinical trial for the treatment of Parkinson’s disease, its Phase I clinical trial for the treatment of epilepsy, and for corporate purposes….
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Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research Tuesday December 4, 8:31 am ET
…biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today the receipt of a grant from the Epilepsy Research Foundation (ERF), a unique joint venture of three non-profit epilepsy organizations -- the Epilepsy Therapy Project (ETP), Epilepsy Foundation (EF), and Finding a Cure for Epilepsy and Seizures (FACES) -- to identify and accelerate the development of promising epilepsy research. The grant will help fund a Phase I human clinical study of Neurologix’s proprietary gene transfer approach to the treatment of epilepsy. The Company expects to initiate this study by early 2008, subject to final authorization from the United States Food and Drug Administration….
…Neurologix seeks to inhibit seizures caused by temporal lobe epilepsy and to reduce the invasiveness of current surgical treatment approaches by targeting a specific area within the brain, called the hippocampus, and delivering healthy genes where faulty or diminishing ones are causing the central nervous system disorder. In particular, Neurologix will seek to deliver the human Neuropeptide Y (NPY) gene, one of the brain’s endogenous anticonvulsants, to neurons in the hippocampus where NPY will act on receptors to inhibit the brain over-activity that occurs during seizures. This approach builds on experience Neurologix has gained through its similar gene transfer approach to treating Parkinson’s disease, where the company is preparing to begin Phase II human clinical trials…. --------------------------------------------
All in all, early ’08 looks to be pretty exciting. Not to say management and others won’t be taking their homage along the way.
Posted by BooDog on :
SWEEEEEEEEET!!!!!!!!!!!
News for 'NRGX' - (Neurologix Gene Therapy Approach to Parkinson's Disease Granted Fast Track Designation From FDA)
FORT LEE, N.J., Dec 13, 2007 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotech company engaged in the research and development of innovative gene therapies for the brain and central nervous system, announced today that the U.S. Food and Drug Administration has granted Fast Track Designation for the company's experimental gene transfer procedure for the treatment of advanced Parkinson's disease.
The Neurologix procedure delivers a gene (glutamic acid decarboxylase, or GAD) to the subthalamic nucleus of the brain, where it makes an inhibitory neurotransmitter called GABA that helps to quiet the abnormal brain activity that is correlated with motor deficits characterizing Parkinson's disease. Results of a Phase 1 clinical study showed that the Neurologix gene transfer procedure was both well tolerated and resulted in improved motor function and brain metabolism for patients with advanced Parkinson's disease over the course of the one-year study. Neurologix is currently preparing to initiate a Phase 2 study of its Parkinson's disease treatment by early 2008, subject to final FDA consent to the study protocol.
"The FDA's Fast Track Designation for this gene transfer procedure for Parkinson's disease recognizes the need for new therapies for patients with advanced Parkinson's disease who no longer receive adequate benefit from their drug therapies alone," said John Mordock, President and Chief Executive Officer of Neurologix.
Under the FDA Modernization Act of 1997, Fast Track Designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Fast Track Designation will provide various means to expedite the development and review of the Neurologix gene transfer procedure for Parkinson's disease, including the facilitation of meetings and other correspondence with FDA reviewers, consideration for priority review, and the ability to submit portions of a Biologics License Application (BLA) early for review as part of a "rolling" submission. The receipt of Fast Track Designation does not, however, assure the approval of any of Neurologix's study protocols or the ultimate approval of any BLA that may be submitted by Neurologix to FDA for marketing approval.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is a development-stage company and has not generated any revenues. From inception through September 30, 2007, it incurred net losses and negative cash flows from operating activities of approximately $26.2 million and $20.3 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
In addition to the recently completed financing, in order to obtain the regulatory approvals necessary to commercialize its current or future product candidates, from time to time the Company will need to raise funds through public or private equity offerings, debt financings or additional corporate collaboration and licensing arrangements. Availability of financing depends upon a number of factors beyond the Company's control, including market conditions and interest rates. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase I safety trial for the treatment of epilepsy.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2006 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SUBJECT CODE: Product/Service
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1.20
Posted by BooDog on :
1.25
Posted by BooDog on :
24-Jan-2008
Other Events
Item 8.01. Other Events. Plan of Operation- - Epilepsy
As a result of recent comments from, and discussions with, the Food and Drug Administration ("FDA") with respect to the Investigational New Drug ("IND") application filed by Neurologix, Inc. (the "Company") for a Phase I clinical trial in temporal lobe epilepsy, the Company has decided to conduct an additional preclinical study in non-human primates. Such study will be designed to confirm the safety of the administration and use of the adeno-associated virus expressing Neuropeptide Y (rAAV1-NPY).
The Company plans to work closely with the FDA to design a protocol with respect to this additional preclinical study, and until such protocol is agreed upon, the Company is unable to estimate the total time or costs involved in conducting such trial. In this regard, the commencement of its Phase I clinical trial will depend on the successful completion of this additional preclinical study. At the present time, the Company does not, however, expect that the study will result in significant changes to the protocol submitted by it to the FDA for the Phase I clinical trial. (See "Risk Factors - The Company Cannot Ensure that it Can Pursue Subsequent Trials for its Product Candidates or the Timing of any such Trials"; "Risk Factors - The Company is Subject to Stringent Regulation; FDA Approvals"; and "Risk Factors - The Company Will Need to Conduct Significant Additional Research and Testing Before Conducting Clinical Trials Involving Future Product Candidates" in the Company's 2006 Form 10-KSB).
NEUROLOGIX INC (OTC BB:NRGX.OB)
Last Trade: 1.10 Trade Time: Jan 23 Change: 0.00 (0.00%) Prev Close: 1.10 Open: N/A Bid: N/A Ask: N/A 1y Target Est: N/A
News for 'NRGX' - (DJ Neurologix To Conduct Added Preclinical Study On Epilepsy Drug) DOW JONES NEWSWIRES
Neurologix Inc. (NRGX) will conduct an additional preclinical study in non-human primates of a gene therapy, according to a document filed Thursday with the Securities and Exchange Commission.
The additional study is the result of recent comments from, and discussions with, the Food and Drug Administration about its investigational new drug application for a Phase I clinical trial in temporal lobe epilepsy.
Neurologix said the study will be designed to confirm the safety of the administration and use of the adeno-associated virus expressing "Neuropeptide Y."
The biotech company, which is engaged in the research and development of innovative gene therapies for the brain and central nervous systems, plans to work closely with the FDA to design a protocol with respect to this additional preclinical study.
The beginning of its Phase I clinical trial will depend on the successful completion of this additional preclinical study, the filing said.
At the present time, the company said it doesn't expect that the study will result in significant changes to the protocol submitted to the FDA for the Phase I clinical trial.
Shares of the company's stock closed Wednesday at $1.10.
-Chad Clinton, Dow Jones Newswires; 202-862-1349; chad.clinton*dowjones.com
(END) Dow Jones Newswires
January 24, 2008 07:25 ET (12:25 GMT)
Copyright (c) 2008 Dow Jones & Company, Inc.- - 07 25 AM EST 01-24-08
Source: DJ Broad Tape
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Neurologix to Present at Roth Capital Partners 2008 OC Growth Conference Thursday February 14, 8:57 am ET Presentation to be Webcast on February 21, 2008
FORT LEE, N.J.--(BUSINESS WIRE)--Neurologix, Inc. (OTCBB: NRGX - News), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that John Mordock, the company’s President and Chief Executive Officer, will present at the Roth Capital Partners 20th Annual OC Conference. The conference will be held February 18-21 at The Ritz-Carlton, Laguna Niguel in Dana Point, CA. ADVERTISEMENT
Mr. Mordock will be making his presentation on February 21 at 09:30 am Pacific Time. The presentation will be broadcast live on the internet at http://www.wsw.com/webcast/roth16/nrgx/.
Founded in 1984, Roth Capital Partners, LLC is an independent investment bank dedicated to emerging growth companies in the small and micro-cap market. For more information about the conference, see http://www.rothcp.com/main/Page.aspx?PageID=7010.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson’s disease, epilepsy and Huntington’s chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
Contact: Neurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Ellen M Martin, 510-832-2044 (Media) emm4*pacbell.net
-------------------------------------------------------------------------------- Source: Neurologix, Inc.
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$1.00
News for 'NRGX' - (Neurologix Receives FDA Clearance to Initiate Phase 2 Trial in Parkinson's Disease Subjects Multicenter U.S. Clinical Study to Initiate in Q2 2008)
FORT LEE, N.J., Mar 27, 2008 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX) a biotechnology company engaged in the research and development of innovative gene therapies for the brain and central nervous system, announced today that the U.S. Food and Drug Administration has allowed the company to proceed with its planned Phase 2 clinical trial in subjects with advanced Parkinson's disease. The company has developed a novel gene transfer approach to treating patients with Parkinson's disease who no longer receive adequate benefit from current drug therapies.
"Given the current cautious regulatory environment surrounding gene therapy in general, receiving the go-ahead from FDA to begin our Phase 2 study represents the crossing of a major hurdle for the development of our gene transfer procedure for Parkinson's disease," said John Mordock, President and Chief Executive Officer. "We have been contracting with clinical sites and reviewing prospective trial subjects for this study, which should begin patient enrollment during the second quarter."
The goal of the Phase 2 clinical trial is to further determine safety of the Neurologix gene transfer therapy and to confirm the initial efficacy reported in the Company's Phase 1 clinical trial. The randomized, blinded study will take place at up to ten centers across the United States, and will enroll approximately 44 subjects with advanced Parkinson's disease.
For additional information on the Neurologix completed Phase 1 clinical trial and the planned Phase 2 clinical trial in advanced Parkinson's disease, please visit http://www.clinicaltrials.gov.
About Neurologix's Gene Transfer Procedure for Parkinson's Disease
The Neurologix procedure delivers a gene (glutamic acid decarboxylase, or GAD) to the subthalamic nucleus of the brain, where it makes an inhibitory neurotransmitter called GABA that helps to quiet the abnormal brain activity that is correlated with motor deficits characterizing Parkinson's disease. Results of the Phase 1 clinical trial showed that the Neurologix gene transfer procedure was both well tolerated and resulted in improved motor function and brain metabolism for patients with advanced Parkinson's disease over the course of the one-year trial. In December 2007, Neurologix received Fast Track Designation from FDA for the gene transfer procedure. This Fast Track designation does not assure the approval of any of Neurologix's clinical study protocols or the ultimate approval of any Biologics License Application that the company may submit for marketing approval. However, it may help expedite the development and FDA's review of this innovative treatment approach.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and Central Nervous System (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through December 31, 2007, it incurred net losses and negative cash flows from operating activities of approximately $28.0 million and $21.6 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At December 31, 2007, the Company had cash and cash equivalents of $20.2 million, which management believes will be sufficient to fund the Company's operations through June 30, 2009. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase 1 safety trial for the treatment of epilepsy.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
scottie says news on the way. Been getting some jiggles. Still pretty low volumes though. Posted by BooDog on :
“Over the past quarter, we have been completing preparations at each of the institutions across the United States that will be participating in the Phase 2 clinical trial of our investigational gene therapy procedure for the treatment of Parkinson’s disease,” said Mr. Mordock. “We expect to announce the start of enrollment in the near future for this important study, which is designed to demonstrate efficacy as well as safety for our novel gene transfer procedure.”
On August 12, 2008, Neurologix, Inc. (the “Company”) entered into an Addendum (the “Addendum”), effective as of August 1, 2008, to its Development and Manufacturing Agreement (the “Development Agreement”), dated as of April 27, 2005, with Medtronic, Inc. (“Medtronic”). The Addendum supplements and clarifies the rights and obligations of each of the Company and Medtronic under the Development Agreement in preparation of the Company’s Phase 2 clinical trial for its Parkinson’s disease product.
Neurologix Initiates Recruitment for Phase 2 Parkinson's Disease Trial Tuesday August 19, 8:00 am ET Multicenter Study of Novel Gene Transfer Approach
FORT LEE, N.J.--(BUSINESS WIRE)--Neurologix, Inc. (OTCBB:NRGX - News), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that it has received Institutional Review Board approvals to begin recruiting and enrolling participants for its Phase 2 clinical trial of the company’s gene transfer approach to the treatment of advanced Parkinson’s disease. The study is designed to evaluate the safety and efficacy of a novel non-dopaminergic approach for reestablishing motor function in Parkinson’s patients who are sub-optimally responsive to drug therapies. ADVERTISEMENT
The randomized, double-blind, sham-procedure controlled trial will involve up to 10 leading academic research centers across the United States, with the first sites being Massachusetts General Hospital and Wake Forest University Health Sciences. Neurologix expects to enroll a total of 40 study participants in the trial. Twenty participants will receive an infusion of the gene-based treatment bilaterally via a catheter temporarily placed in each subthalamic nucleus (STN) (a deep brain structure that is the main target of surgery to treat Parkinson’s disease) by stereotactic surgery. The other 20 participants will receive sterile saline solution into a partial thickness burr hole made into the skull, with no brain infusion.
Study participants will be assessed for treatment effects by standardized Parkinson’s disease ratings at multiple time points post-procedure. The primary endpoint for the study will be a clinical assessment of motor function at 6 months using the Unified Parkinson’s Disease Rating Scale (UPDRS). All participants in the study will also be monitored for safety for 12 months following the gene transfer procedure. If the primary endpoint is met following the analysis of 6 month data, then the sham-control participants will be offered the opportunity to crossover into an open label study of the Neurologix gene transfer therapy if they continue to meet all entry, medical and surgical criteria.
“Parkinson’s disease is a devastating illness for those patients whose symptoms are no longer well controlled by medication alone,” said John Mordock, President and Chief Executive Officer of Neurologix. “We are very pleased to initiate this study, which may offer a new therapeutic option that is potentially disease modifying and more consistent with the brain’s normal metabolic activity.”
About the Neurologix Gene Transfer Approach to Parkinson’s Disease
In Parkinson’s disease, patients lose dopamine-producing brain cells, which results in substantial reductions in the activity and amount of GABA (gamma-aminobutyric acid), a major inhibitory neurotransmitter in the brain that helps ‘quiet’ excessive neuronal firing. This reduction in GABA causes a dysfunction in brain circuitry responsible for coordinating movement. GABA is made by a gene called glutamic acid decarboxylase, or GAD.
Neurologix’s gene transfer approach to Parkinson’s disease seeks to restore GABA -- and thus improve the patient’s motor control -- by inserting the GAD gene back into an area of the brain called the subthalamic nucleus, a key regulatory center for movement.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current company programs address such conditions as Parkinson’s disease, epilepsy and Huntington’s chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words “expects,” “promises,” “anticipates,” “estimates,” “plans,” “intends,” “projects,” “predicts,” “believes,” “may” or “should,” and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company’s management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is still in the development stage and has not generated any revenues. From inception through June 30, 2008, it incurred net losses and negative cash flows from operating activities of approximately $31.3 million and $25.0 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability. At June 30, 2008, the Company had cash and cash equivalents of approximately $21.6 million, which management believes will be sufficient to fund the Company’s operations through at least December 31, 2009. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders. The Company will need to conduct future clinical trials for treatment of Parkinson’s disease using the Company’s NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed. There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase 1 clinical trial for the treatment of epilepsy. Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management’s expectations is found in the section entitled “Risk Factors” in the Company’s 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company’s expectations.
Contact: Neurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 (Media) Jkureczka*comcast.net
-------------------------------------------------------------------------------- Source: Neurologix, Inc.
Posted by BooDog on :
up .10 on 6k
.80 2 at .80 1 at .65
looooow volume.
Posted by BooDog on :
News for 'NRGX' - (Neurologix Licenses Exclusive Rights to Key Gene from Aegera Therapeutics for Use as a Potential Gene Therapy for Huntington's Disease)
FORT LEE, N.J., Sep 03, 2008 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB: NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, and Aegera Therapeutics, a private clinical stage company focused on oncology and neuropathic pain, announced today their execution of an exclusive license agreement. Pursuant to the agreement, Neurologix has exclusively licensed the worldwide rights, excluding China, for the use of the XIAP gene (x-linked inhibitor of apoptosis protein) for therapeutic or prophylactic purposes in the treatment of Huntington's disease. Financial details of the transaction were not disclosed.
Huntington's disease is an inherited neurodegenerative disease that results in uncontrolled movements, deterioration of mental abilities and, ultimately, death. Neuronal cell death associated with the disease is believed to occur via apoptosis, the process of programmed cell death. XIAP is a potent inhibitor of caspases, a family of proteins that are key executors of apoptosis, and therefore it may offer utility as a therapeutic neuroprotective factor. In preclinical studies, Neurologix scientists have demonstrated that a mutated form of the XIAP gene delivered by an adeno-associated virus (AAV) vector can not only slow the disease, but actually normalize motor deficits associated with the disease when introduced into the brain of mice harboring the same mutation found in humans using standard neurosurgical techniques.
"Obtaining the rights to this intellectual property represents an important step in developing a novel therapeutic product for the treatment of this terrible and currently untreatable disease," said John Mordock, President & Chief Executive Officer of Neurologix. "We have been very encouraged by our preclinical results to date, which demonstrate that XIAP may not only modify the progression of cell death, but may potentially reverse neuronal dysfunction as well.
Mr. Mordock added, "We are looking forward to moving this indication toward human clinical trials in patients affected by Huntington's disease. Having successfully completed a Phase 1 clinical trial for the treatment of Parkinson's disease with our AAV-GAD, we are now commencing a Phase 2 clinical trial for that product. Our progress in the Huntington's indication demonstrates the potential of our AAV-mediated gene transfer approach as a common delivery platform for the treatment of various CNS movement disorders and neurodegenerative diseases."
Dr. Michael Berendt, Aegera President and CEO, stated, "We are very excited about the possibility of a new treatment for this devastating disease, and continue to believe that the Inhibitor of Apoptosis protein family, discovered by our founders, plays a central role in multiple disease indications. This licensing transaction with Neurologix highlights our strategy of advancing our own clinical and discovery programs, in our core areas of oncology, neuropathic pain and auto-immune/inflammatory diseases, while working with key strategic partners in other areas to accelerate the delivery of new therapeutics and diagnostics for a wide range of human diseases."
About Huntington's Disease
Huntington's disease, also known as Huntington's chorea, is a genetic neurodegenerative disease caused by a single defective gene on chromosome 4. This leads to damage over time of the nerve cells in areas of the brain including the basal ganglia and cerebral cortex, and to the gradual onset of physical, mental and emotional changes. No cure for Huntington's disease currently exists, so symptoms are managed with various medications and supportive services. The U.S. National Institute of Neurological Diseases and Stroke (NINDS) estimates that at least 150,000 individuals are at risk of developing the disease; children with an affected parent have a 50% chance of inheriting the mutated gene responsible for the condition.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused on developing drugs that control apoptosis to address major unmet medical needs. Aegera has three programs in clinical development:
-- AEG35156 targets the key anti-apoptotic protein XIAP, and is currently in multiple Phase II human clinical trials for the treatment of solid tumors and leukemia;
-- AEG40826/HGS1029 is a novel, small molecule inhibitor of multiple IAP family members, in clinical development for oncology.
-- AEG33773 is a novel, orally bioavailable small molecule developed to treat painful diabetic neuropathy and is in Phase I clinical studies.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current Company programs address such conditions as Parkinson's disease, epilepsy and Huntington's disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of Neurologix that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through June 30, 2008, it incurred net losses and negative cash flows from operating activities of approximately $31.3 million and $25.0 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At June 30, 2008, the Company had cash and cash equivalents of approximately $21.6 million, which management believes will be sufficient to fund the Company's operations through at least December 31, 2009. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such permission will be granted.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix Marc Panoff Chief Financial Officer, Treasurer and Secretary 201-592-6451 marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka 415-821-2413 Jkureczka*comcast.net or Aegera Donald Olds, MSc, MBA Chief Operating Officer & CFO 514-288-5532 ext. 295 donald.olds*aegera.com
Copyright Business Wire 2008
-0-
KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Genetics
Pharmaceutical
Research
Science
SUBJECT CODE: Contract/Agreement
Source: Comtext Market News
Posted by BooDog on :
News for 'NRGX' - (Neurologix Licenses Exclusive Rights to Key Gene from Aegera Therapeutics for Use as a Potential Gene Therapy for Huntington's Disease)
FORT LEE, N.J., Sep 03, 2008 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB: NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, and Aegera Therapeutics, a private clinical stage company focused on oncology and neuropathic pain, announced today their execution of an exclusive license agreement. Pursuant to the agreement, Neurologix has exclusively licensed the worldwide rights, excluding China, for the use of the XIAP gene (x-linked inhibitor of apoptosis protein) for therapeutic or prophylactic purposes in the treatment of Huntington's disease. Financial details of the transaction were not disclosed.
Huntington's disease is an inherited neurodegenerative disease that results in uncontrolled movements, deterioration of mental abilities and, ultimately, death. Neuronal cell death associated with the disease is believed to occur via apoptosis, the process of programmed cell death. XIAP is a potent inhibitor of caspases, a family of proteins that are key executors of apoptosis, and therefore it may offer utility as a therapeutic neuroprotective factor. In preclinical studies, Neurologix scientists have demonstrated that a mutated form of the XIAP gene delivered by an adeno-associated virus (AAV) vector can not only slow the disease, but actually normalize motor deficits associated with the disease when introduced into the brain of mice harboring the same mutation found in humans using standard neurosurgical techniques.
"Obtaining the rights to this intellectual property represents an important step in developing a novel therapeutic product for the treatment of this terrible and currently untreatable disease," said John Mordock, President & Chief Executive Officer of Neurologix. "We have been very encouraged by our preclinical results to date, which demonstrate that XIAP may not only modify the progression of cell death, but may potentially reverse neuronal dysfunction as well.
Mr. Mordock added, "We are looking forward to moving this indication toward human clinical trials in patients affected by Huntington's disease. Having successfully completed a Phase 1 clinical trial for the treatment of Parkinson's disease with our AAV-GAD, we are now commencing a Phase 2 clinical trial for that product. Our progress in the Huntington's indication demonstrates the potential of our AAV-mediated gene transfer approach as a common delivery platform for the treatment of various CNS movement disorders and neurodegenerative diseases."
Dr. Michael Berendt, Aegera President and CEO, stated, "We are very excited about the possibility of a new treatment for this devastating disease, and continue to believe that the Inhibitor of Apoptosis protein family, discovered by our founders, plays a central role in multiple disease indications. This licensing transaction with Neurologix highlights our strategy of advancing our own clinical and discovery programs, in our core areas of oncology, neuropathic pain and auto-immune/inflammatory diseases, while working with key strategic partners in other areas to accelerate the delivery of new therapeutics and diagnostics for a wide range of human diseases."
About Huntington's Disease
Huntington's disease, also known as Huntington's chorea, is a genetic neurodegenerative disease caused by a single defective gene on chromosome 4. This leads to damage over time of the nerve cells in areas of the brain including the basal ganglia and cerebral cortex, and to the gradual onset of physical, mental and emotional changes. No cure for Huntington's disease currently exists, so symptoms are managed with various medications and supportive services. The U.S. National Institute of Neurological Diseases and Stroke (NINDS) estimates that at least 150,000 individuals are at risk of developing the disease; children with an affected parent have a 50% chance of inheriting the mutated gene responsible for the condition.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused on developing drugs that control apoptosis to address major unmet medical needs. Aegera has three programs in clinical development:
-- AEG35156 targets the key anti-apoptotic protein XIAP, and is currently in multiple Phase II human clinical trials for the treatment of solid tumors and leukemia;
-- AEG40826/HGS1029 is a novel, small molecule inhibitor of multiple IAP family members, in clinical development for oncology.
-- AEG33773 is a novel, orally bioavailable small molecule developed to treat painful diabetic neuropathy and is in Phase I clinical studies.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current Company programs address such conditions as Parkinson's disease, epilepsy and Huntington's disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of Neurologix that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through June 30, 2008, it incurred net losses and negative cash flows from operating activities of approximately $31.3 million and $25.0 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At June 30, 2008, the Company had cash and cash equivalents of approximately $21.6 million, which management believes will be sufficient to fund the Company's operations through at least December 31, 2009. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such permission will be granted.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix Marc Panoff Chief Financial Officer, Treasurer and Secretary 201-592-6451 marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka 415-821-2413 Jkureczka*comcast.net or Aegera Donald Olds, MSc, MBA Chief Operating Officer & CFO 514-288-5532 ext. 295 donald.olds*aegera.com
Copyright Business Wire 2008
-0-
KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Genetics
Pharmaceutical
Research
Science
SUBJECT CODE: Contract/Agreement
Source: Comtext Market News
Posted by BooDog on :
News for 'NRGX' - (Neurologix Licenses Exclusive Rights to Key Gene from Aegera Therapeutics for Use as a Potential Gene Therapy for Huntington's Disease)
FORT LEE, N.J., Sep 03, 2008 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB: NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, and Aegera Therapeutics, a private clinical stage company focused on oncology and neuropathic pain, announced today their execution of an exclusive license agreement. Pursuant to the agreement, Neurologix has exclusively licensed the worldwide rights, excluding China, for the use of the XIAP gene (x-linked inhibitor of apoptosis protein) for therapeutic or prophylactic purposes in the treatment of Huntington's disease. Financial details of the transaction were not disclosed.
Huntington's disease is an inherited neurodegenerative disease that results in uncontrolled movements, deterioration of mental abilities and, ultimately, death. Neuronal cell death associated with the disease is believed to occur via apoptosis, the process of programmed cell death. XIAP is a potent inhibitor of caspases, a family of proteins that are key executors of apoptosis, and therefore it may offer utility as a therapeutic neuroprotective factor. In preclinical studies, Neurologix scientists have demonstrated that a mutated form of the XIAP gene delivered by an adeno-associated virus (AAV) vector can not only slow the disease, but actually normalize motor deficits associated with the disease when introduced into the brain of mice harboring the same mutation found in humans using standard neurosurgical techniques.
"Obtaining the rights to this intellectual property represents an important step in developing a novel therapeutic product for the treatment of this terrible and currently untreatable disease," said John Mordock, President & Chief Executive Officer of Neurologix. "We have been very encouraged by our preclinical results to date, which demonstrate that XIAP may not only modify the progression of cell death, but may potentially reverse neuronal dysfunction as well.
Mr. Mordock added, "We are looking forward to moving this indication toward human clinical trials in patients affected by Huntington's disease. Having successfully completed a Phase 1 clinical trial for the treatment of Parkinson's disease with our AAV-GAD, we are now commencing a Phase 2 clinical trial for that product. Our progress in the Huntington's indication demonstrates the potential of our AAV-mediated gene transfer approach as a common delivery platform for the treatment of various CNS movement disorders and neurodegenerative diseases."
Dr. Michael Berendt, Aegera President and CEO, stated, "We are very excited about the possibility of a new treatment for this devastating disease, and continue to believe that the Inhibitor of Apoptosis protein family, discovered by our founders, plays a central role in multiple disease indications. This licensing transaction with Neurologix highlights our strategy of advancing our own clinical and discovery programs, in our core areas of oncology, neuropathic pain and auto-immune/inflammatory diseases, while working with key strategic partners in other areas to accelerate the delivery of new therapeutics and diagnostics for a wide range of human diseases."
About Huntington's Disease
Huntington's disease, also known as Huntington's chorea, is a genetic neurodegenerative disease caused by a single defective gene on chromosome 4. This leads to damage over time of the nerve cells in areas of the brain including the basal ganglia and cerebral cortex, and to the gradual onset of physical, mental and emotional changes. No cure for Huntington's disease currently exists, so symptoms are managed with various medications and supportive services. The U.S. National Institute of Neurological Diseases and Stroke (NINDS) estimates that at least 150,000 individuals are at risk of developing the disease; children with an affected parent have a 50% chance of inheriting the mutated gene responsible for the condition.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused on developing drugs that control apoptosis to address major unmet medical needs. Aegera has three programs in clinical development:
-- AEG35156 targets the key anti-apoptotic protein XIAP, and is currently in multiple Phase II human clinical trials for the treatment of solid tumors and leukemia;
-- AEG40826/HGS1029 is a novel, small molecule inhibitor of multiple IAP family members, in clinical development for oncology.
-- AEG33773 is a novel, orally bioavailable small molecule developed to treat painful diabetic neuropathy and is in Phase I clinical studies.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current Company programs address such conditions as Parkinson's disease, epilepsy and Huntington's disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of Neurologix that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through June 30, 2008, it incurred net losses and negative cash flows from operating activities of approximately $31.3 million and $25.0 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At June 30, 2008, the Company had cash and cash equivalents of approximately $21.6 million, which management believes will be sufficient to fund the Company's operations through at least December 31, 2009. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such permission will be granted.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix Marc Panoff Chief Financial Officer, Treasurer and Secretary 201-592-6451 marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka 415-821-2413 Jkureczka*comcast.net or Aegera Donald Olds, MSc, MBA Chief Operating Officer & CFO 514-288-5532 ext. 295 donald.olds*aegera.com
Copyright Business Wire 2008
-0-
KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Genetics
Pharmaceutical
Research
Science
SUBJECT CODE: Contract/Agreement
Source: Comtext Market News
Posted by BooDog on :
.89 hod
lmao, just noticed my puter did a triple post!
Posted by BooDog on :
* ######## = Material omitted pursuant to a request for Confidential Treatment and filed separately with the Commission on the date of filing of this Form 8-K.
Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease
This study is currently recruiting participants. Verified by Neurologix, Inc., November 2008
Sponsored by: Neurologix, Inc.
Information provided by: Neurologix, Inc. ClinicalTrials.gov Identifier: NCT00643890
Purpose The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of patients with medically refractory Parkinson's disease (PD). The gene transfer product, a disabled virus with a gene called GAD, will be infused into the STN bilaterally using stereotactic surgical techniques. The overall goal of this approach is to normalize the activity of the STN and reduce the motor symptoms of PD.
Condition Intervention Phase Parkinson's Disease Genetic: Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus Phase II
NEUROLOGIX INC(OTC BB: NRGX.OB) Last Trade: 0.50 Trade Time: Nov 11 Change: 0.00 (0.00%) Prev Close: 0.50 Open: N/A Bid: 0.28 x 5000 Ask: 0.56 x 2500 1y Target Est: 2.00 Day's Range: N/A - N/A 52wk Range: 0.45 - 1.39 Volume: 0 Avg Vol (3m): 9,637.5 Market Cap: 13.88M P/E (ttm): N/A EPS (ttm): -0.55 Div & Yield
VERY LOW VOLUME. 52 wk low is wrong. Recent lows are .27 and .28
Posted by BooDog on :
News for 'NRGX' - (Neurologix Commences its Phase 2 Clinical Trial of Novel Gene Transfer Approach for Treatment of Parkinson's Disease)
FORT LEE, N.J., Jan 21, 2009 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that it has initiated its Phase 2 clinical trial for the treatment of advanced Parkinson's disease. The first trial participants have undergone surgery at multiple institutions and additional subjects are currently being enrolled.
The purpose of the trial is to validate the safety and efficacy of Neurologix's gene transfer therapy, a novel non-dopaminergic approach to restore motor function in Parkinson's patients who are sub-optimally responsive to available drug therapy. Neurologix's approach is to reestablish the production of GABA (gamma-aminobutyric acid), the major brain inhibitory neurotransmitter that helps "quiet" excessive neuronal firing and has been determined to be deficient in patients in the advanced stages of Parkinson's disease.
John E. Mordock, President and Chief Executive Officer of Neurologix, stated, "Initiating this Phase 2 clinical trial represents a significant milestone. We expect to enroll 40 subjects across six to eight leading U.S. academic research centers, with completion of enrollment expected during the second half of 2009."
In Parkinson's disease there is degeneration of many cells in the central nervous system including those that produce dopamine, which leads to a downstream deficiency in GABA signaling in areas of the brain that regulate movement. Most current therapies and research approaches target dopamine. Mr. Mordock commented, "In contrast, our preclinical and clinical research suggests that directly targeting GABA production rather than dopamine replacement may be a more effective way of improving brain function in late-stage Parkinson's disease while also avoiding the known therapeutic limitations and complications associated with the over-production of dopamine."
The Co-Chairmen of the trial Steering Committee are Dr. Andrew Feigin, Director of the Neu roscience Experimental Therapeutics Research Program at the Feinstein Institute of Medical Research of the North Shore-Long Island Jewish Health System, and Dr. Peter LeWitt, a neurologist who directs the Parkinson's Disease and Movement Disorders Program at Henry Ford Hospital in Southfield, Michigan.
"Based on the encouraging functional and imaging results seen in the Phase 1 study of this innovative approach to improving Parkinson's disease, we are extremely excited to be part of this study," said Dr. Feigin.
Dr. LeWitt added, "The start of this clinical trial provides hope to the patient population which has had a longstanding need for new treatment options."
The scientific underpinnings of Neurologix's approach have undergone rigorous peer review resulting in highly cited articles in Nature Genetics and Science by the company's co-founders, Drs. Matthew During and Michael Kaplitt. Moreover, the current trial follows a succ essful Phase 1 study, as published in the Lancet and Proceedings of the National Academy of Sciences, USA, in which 12 subjects completed the study showing no related serious adverse events and significant functional benefit with supportive imaging data.
Phase 2 Clinical Trial Design
As previously announced, 20 participants will receive an infusion of the gene-based treatment bilaterally via a catheter temporarily placed by stereotactic surgery in each participant's subthalamic nucleus (STN), a deep brain structure that is the main target of surgery to treat Parkinson's disease. The other 20 participants will receive sterile saline solution into a partial thickness burr hole made into the skull, with no brain infusion. Trial participants will be assessed for treatment effects by standardized Parkinson's disease ratings at multiple time points post-procedure. The primary endpoint for the trial will be a clinical assessment of mot or function at 6 months using the Unified Parkinson's Disease Rating Scale (UPDRS). All participants in the trial will also be monitored for safety for 12 months following the gene transfer procedure. If the primary endpoint is met following the analysis of 6 month data, then the sham-control participants will be offered the opportunity to crossover into an open label study of the Neurologix gene transfer therapy if they continue to meet all entry, medical and surgical criteria.
About the Neurologix Gene Transfer Approach to Parkinson's Disease
In Parkinson's disease, patients lose dopamine-producing brain cells, resulting in substantial reductions in the activity and amount of GABA (gamma-aminobutyric acid). This reduction in GABA causes a dysfunction in brain circuitry responsible for coordinating movement. GABA is made by a gene called glutamic acid decarboxylase, or GAD.
Neurologix's gene transfer approach to Parkinson's disease seeks to restore GABA -- and thus improve the patient's motor control -- by inserting the GAD gene back into an area of the brain called the subthalamic nucleus, a key regulatory center for movement.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological il lnesses. Current programs of the company address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concer ning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through September 30, 2008, it incurred net losse s and negative cash flows from operating activities of approximately $32.9 million and $26.5 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, the Company may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At September 30, 2008, the Company had cash and cash equivalents of approximately $20.1 million, which management believes will be sufficient to fund the Company's operations through at least March 31, 2010. The Company does not know whether additional financing will be available when needed, or if available, will be on accepta ble or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully receive approval from the Food and Drug Administration (FDA) on its Investigational New Drug Application to commence a Phase 1 clinical trial for the treatment of epilepsy
-- There is no assurance as to when, of if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such per mission will be granted.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2007 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: N eurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 Jkureczka*comcast.net
Copyright Business Wire 2009
-0-
KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Clinical Trials
&n bsp; Mental Health
Pharmaceutical
Research
Science
Source: Comtext Market News
Posted by BooDog on :
May want to watch Frontline on PBS tomorrow at 9pm. A story about Parkinsons.
Posted by BooDog on :
News for 'NRGX' - (Neurologix to Present at Roth Capital Partners 2008 OC Growth Conference -- Presentation to be Web Cast on February 16, 2009 --)
FORT LEE, N.J., Feb 09, 2009 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene t herapies for the brain and central nervous system, announced today that John Mordock, the company's Chief Executive Officer, will present at the Roth Capital Partners', 21th Annual OC Conference. The conference will be held February 16-18 at The Ritz Carlton Laguna Niguel in Dana Point, CA.
Mr. Mordock will be making his presentation on February 16 at 2:20 PM Pacific Time. The presentation will be broadcast live on the internet at http://www.wsw.com/webcast/roth20/nrgx/
Founded in 1984, Roth Capital Partners, LLC is an independent investment bank dedicated to emerging growth companies in the small and micro-cap market. For more information about the conference, see http://www.roth.com/main/Page.aspx?PageID=7214
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disor ders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current programs of the company address such conditions as Parkinson's disease, epilepsy and Huntington's chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Media: Joan Kureczka, 415-821 2413 jkureczka*comcast.net
Copyright Business Wire 2009
-0-
< BR>
KEYWORD: United States
North America
California
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Clinical Trials
Pharmaceutical
SUBJECT CODE: Conference
Trade Show
Webcast
Source: Comtext Market News
Posted by BooDog on :
Webcast NEUROLOGIX INC at Roth Capital Partners 21st Annual OC Growth Stock Conference (Replay) 02/16/09 at 2:20 p.m. PT http://www.wsw.com/webcast/roth20/nrgx/ - - ------------------------------------------------- UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
February 19, 2009
ORDER GRANTING CONFIDENTIAL TREATMENT
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Neurologix, Inc.
File No. 000-13347 - CF# 23100
______________________
Neurologix, Inc. submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the Exhibits to a Form 8-K filed on January 14, 2009.
Based on representations by Neurologix, Inc. that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be released to the public for the time period(s) specified:
Exhibit 10.1 through January 13, 2019
For the Commission, by the Division of Corporation Finance, pursuant to delegated authority:
News for 'NRGX' - (Neurologix Announces Year End 2008 Results)
FORT LEE, N.J., Mar 26, 2009 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, today announced its financial re sults for the year ended December 31, 2008.
For the year ended December 31, 2008, Neurologix reported a net loss of $6.3 million, as compared with a net loss of $6.8 million for the year ended December 31, 2007. The Company reported a net loss applicable to common stock for the year ended December 31, 2008 of $9.7 million, or $0.35 per basic and diluted share, as compared with a net loss applicable to common stock for the year ended December 31, 2007 of $13.8 million, or $0.51 per basic and diluted share. The net loss applicable to common stock for the year ended December 31, 2008, includes charges of $3.4 million, or $0.12 per basic and diluted share, related to preferred stock dividends ($2.6 million) and beneficial conversion features ($0.8 million) in connection with the Company's Series C Convertible Preferred Stock and Series D Convertible Preferred Stock. The net loss applicable to common stock for the year ended December 31, 2007 included charges of $7.0 million, or $0.26 per basic and diluted share, related to induced conversion of preferred stock ($2.8 million), accretion of beneficial conversion features ($2.8 million) and preferred stock dividends ($1.4 million) in connection with the issuance of the Company's Series D Convertible Preferred Stock and amendments to the Company's outstanding Series C Convertible Preferred Stock. The Company had cash and cash equivalents of approximately $18.9 million as of December 31, 2008.
In commenting on the Company's performance, John E. Mordock, President and Chief Executive Officer said, "Neurologix ended 2008 with the achievement of a significant clinical milestone, the initiation of the planned Phase 2 clinical trial of our gene transfer approach to advanced Parkinson's disease. We will assess each patient six months after the procedure to determine the effects of our experimental Parkinson's disease product on the patient's motor function, using the Unified Parkinson's Disease Rating Scale. We are hopeful that the initial data from this one-year Phase 2 clinical trial will confirm and build upon the success that was demonstrated in our initial Phase 1 clinical trial. The 12 subjects who completed the Phase 1 clinical trial showed no related serious adverse events and realized significant functional benefit that was supported by brain imaging data."
Mr. Mordock also noted that, during 2008, Neurologix expanded its intellectual property portfolio by licensing the exclusive rights to a gene that may have therapeutic or prophylactic uses in the treatment of Huntington's disease. "Obtaining the right to this intellectual property represents an important step in the development of a novel therapeutic approach for the treatment of this disease. We are particularly encouraged by the neuroprotective potential of the gene. Over the coming month s, Neurologix will be further evaluating the opportunities for its gene transfer technology in Huntington's disease, as well as the potential use of this therapeutic approach in such other CNS diseases as depression and refractory epilepsy," he said.
"Given the current difficult economic climate, Neurologix has been prudent in its utilization of capital," Mr. Mordock further stated. "During 2008 we raised $5 million, in addition to the $15 million we raised in late 2007, to ensure that we would have sufficient resources to complete our Phase 2 clinical trial for Parkinson's disease. Our primary focus in 2009 is the completion of this trial and, based upon our financial resources, we anticipate further development of our other indications."
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer thera pies for serious disorders of the brain and central nervous system (CNS). Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current programs of the company address such conditions as Parkinson's disease, Huntington's chorea and epilepsy, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigat ion Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achiev ements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through December 31, 2008, it incurred net losses and negative cash flows from operating activities of approximately $34.3 million and $27.6 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, the Company may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At December 31, 2008, the Company had cash and cash equiva lents of approximately $18.9 million, which management believes will be sufficient to fund the Company's operations through at least June 30, 2010. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
-- There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such permission will be granted.
-- There is no assurance as to when, or if, the Company will be able to successfully receive approval from the Food and Drug Administration (FDA) on its Investigational New Drug Application to commence a Phase 1 clinical trial for the treatment of epilepsy.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2008 Annual Report on Form 10-K. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to up date forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development &nb sp;
Stage Company)
CONDENSED BALANCE SHEETS
(Amounts
in thousands, except share and per share amounts) &n bsp;
&n bsp; December31, December31,
2008 2007
& nbsp;
ASSETS &nb sp;
Current assets:
Cash and cash equivalents ; $ 18,906 $ 20,157
Prepaid expenses and other current assets 323 418
Total current assets 19,229 20,575 &n bsp;
Equipment, less accumulated depreciation of $542 and $437 at 141 231
December 31, 2008 and 2007, respectively
Intangible assets, less accumulated amortization of $182 and $127 at 748 623
De cember 31, 2008 and 2007, respectively
Other assets 5 5
Total Assets & nbsp; $ 20,123 $ 21,434
;
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities: &n bsp;
Accounts payable and accrued expenses $ 850 $ 1,265
Total liabilities 850 1,265
Commitments and contingencies &nb sp;
Stockholders' equity:
Preferred stock; 5,000,000 shares authorized
Series A - Con vertible, $0.10 par value; 650 shares designated, 645 - -
shares issued and outstanding at December 31, 2008 and 2007, with an
aggregate liquidation preference of $1
Series C - Convertib le, $0.10 par value; 700,000 shares designated, 29 30
285,878 and 295,115 shares issued and outstanding at December 31,
2008 and 2007, respectively, with an aggregate liquidation
preference of $5,863 and $6,529 at December 31, 2008 and 2007,
respectively
Series D - Convertible, $0.10 par value; 792,100 shares designated, 73 60 &nbs p;
734,898 and 597,149 shares issued and outstanding at December 31,
2008 and 2007, respectively, with an aggregate liquidation
preference of $27,031 and $22,673, at December 31, 2008 and 2007,
respectively &nbs p;
Common Stock: ;
$0.001 par value; 100,000,000 shares authorized, 27,764,058 and 28 28
27,632,808 shares issued and outstanding at outstanding at December
31, 2008 and 2007, respectively. &nbs p;
Additional paid-in capital 62,393 56,207
Deficit accumulated during the development stage (43,250 ) (36,156 )
Total stockholders' equity &n bsp; 19,273 20,169
Total Liabilities and Stockholders' Equity $ 20,123 $ 21,434
NEUROLOGIX, INC. AND SUBSIDIARY &n bsp;
(A Development &n bsp;
Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts
in thousands, except share and per share amounts) &n bsp;
&nbs p;
Year Ended December 31, For the period
&nb sp; February 12, 1999 (inception) through
&nbs p; December 31, 2008
2008 2007 ;
Revenues $ - $ - $ -
Operating expenses: ;
Research and development 3,929 &n bsp; 4,289 19,617
General and administrative expenses 2,973 3,016 16,100
Charge for accretion of beneficial conversion feature (562 ) (2,130 ) &nb sp;
Charge for contingent beneficial conversion feature related to (212 ) (627 )
Series C Preferred Stock &n bsp;
Charges for induced conversion of Series C Preferred Stock - (2,796 )
Net loss applicable to common stock &n bsp; $ (9,746 ) $ (13,765 )
&n bsp;
Net loss applicable to common stock per share, basic and diluted $ (0.35 ) $ (0.51 )
& nbsp;
Weighted average common shares outstanding, basic and diluted 27,692,337 26,764,087
SOURCE: Neurologix, Inc.
CONTACT: Neurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 Jkureczka*comcast.net
Copyright Business Wire 2009
-0-
KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
&nb sp; Biotechnology
Clinical Trials
Genetics
Pharmaceutical
SUBJECT CODE: Earnings
Source: Comtext Market News
Posted by BooDog on :
still not hardly any volume. asking .34
Depth/Level II for Neurologix Inc. (NRGX) $ 0.74 RT 0.23 (+45.10%) Volume: 3.25 k
but if it wants to walk back up to $$$ land like this that's cool with me too.
Posted by BooDog on :
The Board has fixed the close of business on April 1, 2009 as the record date (the “Record Date”) for the determination of stockholders who are entitled to notice of and to vote at the meeting. As of the Record Date, the outstanding number of voting securities of the Corporation was 28,785,479 shares, consisting of 27,764,058 shares of common stock, par value $0.001 per share (“Common Stock”), 645 shares of Series A convertible preferred stock, par value $0.10 per share (“Series A Preferred Stock”), 285,878 shares of Series C convertible preferred stock, par value $0.10 per share (“Series C Preferred Stock”), and 734,898 shares of Series D convertible preferred stock, par value $0.10 per share (“Series D Preferred Stock”). Holders of a majority of our outstanding shares of Common Stock, Series A Preferred Stock, Series C Preferred Stock and Series D Preferred Stock, considered as a single class, on an as-converted basis, must be present or represented by proxy at the meeting to constitute a quorum. For each share held as of the Record Date, each holder of Common Stock is entitled to one vote per share of Common Stock, each holder of Series A Preferred Stock is entitled to one vote per share of Series A Preferred Stock, each holder of Series C Preferred Stock is entitled to approximately 21.88 votes per share of Series C Preferred Stock and each holder of Series D Preferred Stock is entitled to approximately 30.17 votes per share of Series D Preferred Stock. ----
Nominee For Election As Class III Director
Unless instructed otherwise, the proxies named on the enclosed proxy card intend to vote the shares that they represent to elect John E. Mordock to serve as Class III director.
JOHN E. MORDOCK — Mr. Mordock, age 63, has been a director of the Corporation since November 2005. Mr. Mordock was appointed as the President and Chief Executive Officer of the Corporation on July 17, 2006. Mr. Mordock was a Partner of Red Bird Capital, LLC, a private equity firm focusing on early stage medical technology companies, from January 2001 until July 2006. From 1996 to 2001, Mr. Mordock was President and Chief Executive Officer and a director of Teleflex Instruments & Surgical Services. Mr. Mordock was also President, Chief Operating Officer and a director of Cabot Medical Corporation from 1981 to 1996. Mr. Mordock holds a B.S. and an MBA from La Salle University and an E.P.S.M. from the Graduate School of Business at Stanford University.
Election of the Class III director of the Corporation will require the affirmative vote of a plurality of voting shares held by stockholders present in person or represented by proxy at the meeting and entitled to vote thereat.
THE BOARD RECOMMENDS THAT YOU VOTE “FOR” THE ELECTION OF ITS NOMINEE FOR CLASS III DIRECTOR.
BOARD OF DIRECTORS AND COMMITTEES
Other Directors
The terms of the Class I and Class II directors expire in 2010 and 2011, respectively. Accordingly, these directors are not up for re-election at the meeting.
Class I Directors Continuing in Office with Terms Expiring at the 2010 Annual Meeting of Stockholders
WILLIAM J. GEDALE — Mr. Gedale, age 66, has been a director of the Corporation since May 2007. He is the co-founder of NGN Capital and has been a Managing General Partner thereof since 2003. Mr. Gedale was the President and Chief Executive Officer of Mount Everest Advisors, an investment counseling firm which he founded in 1996. He also served as an investment advisor to individuals and as a consultant to Warburg-Pincus Capital Management, the world’s largest venture capital firm, between 1999 and 2001. Before founding Mount Everest Advisors, he was a Managing Director at John W. Bristol & Co., a privately owned, independent investment advisor, in 1995. From 1969 to 1995, Mr. Gedale was with General American Investors, one of the nation’s oldest closed-end funds, and held various positions, including President and Chief Executive Officer from 1989 to 1995. He is currently Chairman of Promosone, a privately held bioproduction and biopharmaceutical company, and Vice Chairman of Enzybiotics, a privately held biopharmaceutical company working to combat various infectious disease pathogens. He was previously a director of Gamco (Gabelli Holding), General American Investors, Allied Clinical Laboratories, U.S. Home Health Care, Unilab Corporation, and BioReliance Corporation. Mr. Gedale holds an M.B.A. from New York University, a J.D. from Fordham Law School and an A.B. from Syracuse University.
CLARK A. JOHNSON — Mr. Johnson, age 77, has been a director of the Corporation since February 2004. He has been the Chairman of PSS World Medical, Inc., a national distributor of medical equipment and supplies to physicians, hospitals, nursing homes, and diagnostic imaging facilities since October 2000. From August 1985 to June 1998, Mr. Johnson served as Chief Executive Officer of Pier 1 Imports, a specialty retailer of imported decorative home furnishings, gifts and related items, also becoming Chairman in 1988. Currently, Mr. Johnson serves on the board of directors of various private companies, including REFAC Optical Group, a provider of managed vision and professional eye care products and services and an affiliate of Palisade Capital Management, LLC (“PCM”), MetroMedia International Group, an international telecommunications company, World Factory, Inc., an international sourcing and product development company specializing in outdoor living and hardware products and Brain Twist Inc., a specialty drink development company. Mr. Johnson owns 5% of the preferred, non-voting equity interest in PCM.
JEFFREY B. REICH, M.D. — Dr. Reich, age 46, has been a director of the Corporation since February 2005. Since January 2007, Dr. Reich has served as a healthcare analyst at Cramer Rosenthal McGlynn, a New York City-based investment and asset management firm. From 2002 through 2007, Dr. Reich served as a senior analyst and portfolio manager at Merlin Biomed Group, a New York City-based asset management firm that invests globally in public and private healthcare companies. Dr. Reich has also served as an assistant professor of clinical neurology at Weill Medical College of Cornell University since 1995. He received his medical degree from Weill Medical College of Cornell University in 1987. Dr. Reich was initially elected to the Board pursuant to the Stock Purchase Agreement, dated as of February 4, 2005 by and among the Corporation, Merlin Biomed Long Term Appreciation Fund LP and Merlin Biomed Offshore Master Fund LP. (collectively, “Merlin”). This agreement originally gave Merlin the right to appoint Dr. Reich to the Board but has since been amended to eliminate this right.
Class II Directors Continuing in Office with Terms Expiring at the 2011 Annual Meeting of Stockholders
CORNELIUS E. GOLDING — Mr. Golding, age 61, has been a director of the Corporation since August 2006. From 1981 to 2003, Mr. Golding served in various financial roles at Atlantic Mutual Insurance Company (“Atlantic Mutual”), a property and casualty insurance company in Madison, New Jersey. During his tenure with Atlantic Mutual, Mr. Golding first served as vice president of internal audit and comptroller before being appointed as senior vice president. Mr. Golding was promoted to chief financial officer in 1994 and served in this role until his retirement in 2003. Mr. Golding is currently a financial consultant to various property and casualty insurance companies and serves on the boards of directors of the Somerset Hills Bank Corp., a holding company for the Bank of Somerset Hills, a New Jersey bank, and various private companies, including the United Auto Insurance Group of North Miami Beach, Florida. Mr. Golding is a Certified Public Accountant and holds a B.B.A. in accounting from Saint John Fisher College and an M.B.A. in finance from Fairleigh Dickenson University.
ELLIOTT H. SINGER — Mr. Singer, age 68, has been a director of the Corporation since November 14, 2005. Mr. Singer is a Managing Director of FairView Advisors, a financial services firm that he founded in September 2001. Mr. Singer founded and served as the Chief Executive Officer of A+ Network (formerly A+ Communications). Mr. Singer holds a B.A. from Tulane University and an MBA from the Leonard R. Stern School of Business at NYU.
MARTIN J. KAPLITT, M.D. — Dr. Kaplitt, age 70, has been the Chairman of the Board of the Corporation since February 2004. Dr. Kaplitt served as the Executive Chairman of the Corporation from September 2004 until February 23, 2007. He also served as President of the Corporation from February 2004 to September 2004 and was previously a director and president of Neurologix Research, Inc., the Corporation’s predecessor, from August 1999 to February 2004. Dr. Kaplitt has been associated with North Shore University Hospital for over 30 years and has held a variety of positions including: Chief of Thoracic and Cardiovascular Surgery from 1971 to 1978, Associate Attending in Cardiovascular Surgery from 1978 to 2001 and Adjunct Associate Attending in Surgery from 2001 to present. He was also a clinical associate professor of surgery at Cornell University Medical College. Dr. Kaplitt was a director of the Trust Company of New Jersey from 1985 through May 2004, when it was acquired by North Fork Bankcorp of Long Island, NY. Dr. Kaplitt attended Cornell University and the State University of New York, Downstate Medical Center. Dr. Kaplitt is a fellow of the American College of Surgeons and the American College of Cardiology.
------- EXECUTIVE OFFICERS
The Corporation’s current executive officers are: (i) John E. Mordock, President and Chief Executive Officer, appointed on July 17, 2006, (ii) Marc L. Panoff, Chief Financial Officer, Treasurer and Secretary, appointed on January 23, 2006, and (iii) Christine V. Sapan, Executive Vice President, Chief Development Officer, appointed on July 10, 2006. For purposes of this proxy statement, the term “Named Executives” shall mean Messrs. Mordock and Panoff and Dr. Sapan. Set forth below is a brief description of our executive officers who are not described above.
MARC PANOFF — Mr. Panoff, age 38, was appointed as the Chief Financial Officer and Treasurer of the Corporation on January 23, 2006 and appointed as the Corporation’s Secretary on May 9, 2006. Mr. Panoff was the Chief Financial Officer at Nephros, Inc., a publicly traded medical device company, from July 2004 to January 2006. From August 2001 to July 2004, Mr. Panoff was the Vice President, Finance, at Walker Digital Companies, a privately held research and development company. He also served as Corporate Controller at Medicis Pharmaceutical Corporation, a publicly traded specialty pharmaceutical company, for over seven years. Mr. Panoff received his Bachelor of Science in Business Administration from Washington University in St. Louis and his Masters in Business Administration from Arizona State University. He is also a Certified Public Accountant in the state of New York.
CHRISTINE V. SAPAN — Dr. Sapan, age 61, was appointed as the Executive Vice President, Chief Development Officer of the Corporation effective July 10, 2006. Dr. Sapan was previously employed for 18 years at Nabi Biopharmaceuticals, a vertically integrated biopharmaceutical company that focuses on serious unmet medical needs including infectious diseases, most recently serving as Vice President, Project Management from 2001 to 2005. Dr. Sapan has a Ph.D in Experimental Pathology and an M.S. in Human Physiology from the University of North Carolina.
The following table presents the aggregate compensation for services in all capacities paid by the Corporation and its subsidiaries in respect of the years ended December 31, 2007 and 2008 to the Corporation’s Named Executives.
Except as set forth herein, the Named Executives did not receive any compensation from the Corporation during 2007 and 2008.
NEUROLOGIX INC at Neurotech Industry Investing & Partnering Conference Tuesday, May 12, 2009 1:30 p.m. PT
Event Details
Title NEUROLOGIX INC at Neurotech Industry Investing & Partnering Conference Date and Time Tuesday, May 12, 2009 1:30 p.m. PT Location St.Regis Hotel San Francisco, CA
Neurologix to Present at The Neurotech Industry Investing and Partnering Conference 2009 FORT LEE, N.J.--(BUSINESS WIRE)--May. 7, 2009-- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that John Mordock, the company’s Chief Executive Officer, will present at the 4th annual Neurotech Industry Investing and Partnering Conference 2009, to be held May 11-13 at The St. Regis hotel in San Francisco, CA.
Mr. Mordock will be making his presentation on Tuesday May 12 at 1:30 pm as part of a session focused on Neurodegenerative Disease: Alzheimer’s and Parkinson’s.
The Neurotech Industry Investing and Partnering Conference is focused on drugs, devices and diagnostics for the brain and nervous system and is the largest gathering of executives from across commercial neuroscience. For more information on the conference, please visit www.neurotechindustry.org.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current programs of the company address such conditions as Parkinson’s disease, epilepsy and Huntington’s chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
Source: Neurologix, Inc.
Neurologix, Inc. Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff*neurologix.net or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 (Media) jkureczka*comcast.net
Posted by BooDog on :
New Parkinson’s Disease Clinical Trials Are Currently Enrolling Patients Parkinson's disease clinical trials The characteristic symptoms of Parkinson’s disease (PD) are caused by the degeneration of dopamine-producing neurons in the brain. One development in current Parkinson’s research is looking at motor centers in the brain that do not receive enough of a compound called gamma-aminobutyric acid (GABA).
This investigational study is designed to determine if intracranial administration of glutamic acid decarboxylase (GAD), the enzyme that aids in the production of GABA, will help restore normal function in the brain and alleviate the symptoms associated with Parkinson’s disease.
This is a double-blind, randomized, placebo-controlled study. Study participants will be selected randomly to receive either rAAV-GAD, a recombinant viral delivery vector that contains the gene that makes GAD, or sterile saline by infusion into brain cells using an investigational device via a stereotactic neurosurgery procedure. These study participants will receive the study drug or sterile saline, study-related monitoring, and care from study doctors at no cost.
Register to view a live Webcast about this clinical trial for Parkinson’s disease with Michael G. Kaplitt, MD, PhD.
Learn more about this study and how your patients might participate Register to receive more information on this study and to view an informative Webcast about this new investigational clinical trial for Parkinson’s disease.
If you have PD, learn more about this clinical trial Register to receive more information on this study and to view an informative Webcast about this investigational clinical trial for Parkinson’s disease.
Terms and Conditions Privacy Policy Neurologix.net Neurologix, Inc. is the sponsor of this study. Neurologix™ is a trademark of Neurologix, Inc. All rights reserved. Intended for US viewers only. http://www.neurologixpdtrial.com/
excerpt from Mays financial... Neurologix held cash and cash equivalents of approximately $16.9 million at March 31, 2009.
John Mordock, President and Chief Executive Officer of Neurologix, noted that these first quarter financial results were consistent with the Company’s expectations. He further commented, “During the first quarter, Neurologix continued to progress in enrolling patients, opening sites and performing surgeries for a Phase 2 clinical study of our experimental gene-transfer treatment for advanced Parkinson’s disease. We plan to enroll 40 subjects across six to eight leading U.S. academic research centers, with completion of the surgeries expected during the second half of 2009.”
Posted by BooDog on :
Neurologix to Showcase Novel Brain and CNS Disease Gene Therapies at BioPharm America Parkinson’s Disease Phase 2 Trials Ongoing; Huntington’s Disease Nearing the Clinic
Press Release Source: Neurologix, Inc. On Monday September 14, 2009, 10:59 am EDT Buzz up! 0 Print.Companies:Neurologix Inc. FORT LEE, N.J.--(BUSINESS WIRE)--Neurologix, Inc. (OTCBB: NRGX - News), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that the company will showcase its novel gene transfer approach to Parkinson’s disease and other serious brain and central nervous system diseases at the BioPharm America partnering conference being held in San Francisco, CA on September 17 – 18. John Mordock, Neurologix President and Chief Executive Officer, will discuss the company’s technology, ongoing Phase 2 trial in advanced Parkinson’s disease and other development programs from 4:15 – 4:30 on Thursday September 17 in Salon 14 at the Marriott San Francisco.
Related Quotes Symbol Price Change NRGX.OB 0.94 0.00
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system (CNS). Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. Current programs of the company address such conditions as Parkinson’s disease, epilepsy and Huntington’s chorea, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net. Neurologix to Showcase Novel Brain and CNS Disease Gene Therapies at BioPharm America - Yahoo! Finance
Title NEUROLOGIX INC at Rodman & Renshaw Annual Global Investment Conference Date and Time Wednesday, September 9, 2009 2:25 p.m. ET through Wednesday, September 9, 2009 Duration 30 Minutes Location New York, NY
NEUROLOGIX INC(OTC BB: NRGX.OB) Last Trade: 0.94 Trade Time: Sep 11 Change: 0.00 (0.00%) Prev Close: 0.94 Open: N/A Bid: N/A Ask: N/A 1y Target Est: 2.00 Day's Range: N/A - N/A 52wk Range: 0.00 - 1.05 Volume: 0 Avg Vol (3m): 5,175 Market Cap: 26.19M P/E (ttm): N/A EPS (ttm): -0.47 Div & http://stockcharts.com/c-sc/sc?s=NRGX&p=D&yr=0&mn=4&dy=0&i=t05112320065&r=5800 Chart may not go through. 50dma moving back up nice and steady. the B/A is still gapped pretty wide with this very low volume. I've been all over the bid range between .71 and .85 with no fills. currently riding free from the last bounce from .41 (low printed .30) to 1.02. But the MMs don't seem to want to let it drop back down. Still a lot going on with NRGX but also still some time to go before phase III completions. Check out the slide show, webcast Wall Street Webcasting - Neurologix Inc in the previous post. As of August 10, 2009, 27,865,010 shares of common stock were outstanding.
Posted by BooDog on :
Neurologix Gains Broadened U.S. Patent Protection for Its GAD-Based Gene Delivery System
-- New Allowed Claims Extend Protection Beyond Parkinson's Disease to Other Neurological and Related Disorders --
FORT LEE, N.J., Jan 26, 2010 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, announced that the U.S. Patent and Trademark Office (US PTO) has expanded the intellectual property protections enabled by a previously issued patent that is central to Neurologix's Parkinson's disease program. The new allowances to U.S. Patent Number 765,446, entitled "Glutamic acid decarboxylase (GAD) based delivery systems," broaden the patent's coverage beyond Parkinson's disease to include the use of GAD65 in the treatment of other neurological and related disorders. "This broadened coverage for Neurologix's intellectual property in the field of gene-based medicine for brain and CNS diseases further reinforces our leadership position as an innovator in this emerging therapeutic modality," said John Mordock, Neurologix President and Chief Executive Officer. "The covered technology is not only at the core of our Parkinson's disease program, of which Phase 2 initial efficacy results are expected to be announced in mid-2010, but has potential application to other important diseases within our company's core therapeutic focus."
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering gene transfer therapies for serious disorders of the brain and central nervous system. Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. The company's current programs address such conditions as Parkinson's disease, epilepsy and Huntington's disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
-- The Company is still in the development stage and has not generated any revenues. From inception through September 30, 2009, it incurred net losses and negative cash flows from operating activities of approximately $44.9 million and $34.5 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability.
-- At September 30, 2009, the Company had cash and cash equivalents of approximately $11.8 million, which management believes will be sufficient to fund the Company's operations through at least September 30, 2010. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders. If the Company is unable to secure additional funding in the near future, its ability to continue as a going concern may be in doubt.
-- The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information about factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2008 Annual Report on Form 10-K. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
SOURCE: Neurologix, Inc.
CONTACT: Neurologix Marc Panoff, 201-592-6451 Chief Financial Officer, Treasurer and Secretary marcpanoff@neurologix.net or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 (Media) Jkureczka@comcast.net Copyright Business Wire 2010 -0-
KEYWORD: United States North America New Jersey INDUSTRY KEYWORD: Health Biotechnology Genetics Mental Health Pharmaceutical
Posted by BooDog on :
Neurologix Receives Notice of Allowance for Epilepsy Therapeutic Approach -- Patent Addresses Delivery of NPY Gene to Control Seizures --
Buzz up! 0 Print Companies:Neurologix Inc. Related Quotes Symbol Price Change NRGX.OB 0.68 +0.03
{"s" : "nrgx.ob","k" : "c10,l10,p20,t10","o" : "","j" : ""} Press Release Source: Neurologix, Inc. On Monday March 15, 2010, 7:57 am EDT FORT LEE, N.J.--(BUSINESS WIRE)--Neurologix, Inc. (OTCBB:NRGX) today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (US PTO) for intellectual property central to the company’s approach to the treatment of epilepsy. The patent allowance specifically refers to Neurologix’s patent application, “Methods and Compositions for the Treatment of Neurological Disease,” which covers the treatment of seizures associated with temporal lobe epilepsy by direct administration into the brain’s temporal lobe of an AAV vector encoding Neuropeptide Y (NPY). Neurologix is a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, including Parkinson’s disease, epilepsy, Huntington’s disease and other disorders.
“This Notice of Allowance further validates the innovative nature of Neurologix’s proprietary technology platform and approach to the treatment of central nervous system diseases, and underscores our company’s leadership in the emerging field of Molecular Medicine for neurological disorders,” said Martin J. Kaplitt, M.D., Neurologix’s Chairman of the Board. “In the case of refractory temporal lobe epilepsy, we hope to improve on the effectiveness and reduce the invasiveness of current surgical treatments by delivering the human NPY gene directly to the hippocampus of the brain, thereby inhibiting seizures without the need for surgical resection of functional brain tissue, the current standard of care for this disease. Temporal lobe epilepsy, affecting over 1 million patients in the United States, represents a major unmet medical need, where traditional pharmacological therapies have proven unsatisfactory. This strategy builds on the experience Neurologix has gained through our similar gene transfer approach to treating Parkinson’s disease, where we are now awaiting efficacy results from our Phase 2 trial around mid-year.”
Preclinical results published in the Journal of Neuroscience, Epilepsia, Experimental Neurology (2004, 2006, 2009) and the May 2008 issue of Brain have consistently demonstrated the efficacy of Neurologix’s therapeutic approach to temporal lobe epilepsy, including the prevention of spontaneous seizures and suppression of disease progression in chronic epilepsy rodent models.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of life-altering molecular therapeutics for serious disorders of the brain and central nervous system. Neurologix’s therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. The company’s current programs address such conditions as Parkinson’s disease, epilepsy and Huntington’s disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net.
This news release includes certain statements of the Company that may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words “expects,” “promises,” “anticipates,” “estimates,” “plans,” “intends,” “projects,” “predicts,” “believes,” “may” or “should,” and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company’s management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is still in the development stage and has not generated any revenues. From inception through September 30, 2009, it incurred net losses and negative cash flows from operating activities of approximately $44.9 million and $34.5 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability. At September 30, 2009, the Company had cash and cash equivalents of approximately $11.8 million, which management believes will be sufficient to fund the Company’s operations through at least September 30, 2010. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders. If the Company is unable to secure additional funding in the near future, its ability to continue as a going concern may be in doubt. The Company will need to conduct future clinical trials for treatment of Parkinson’s disease using the Company’s NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information about factors that could cause results to differ materially from management’s expectations is found in the section entitled “Risk Factors” in the Company’s 2008 Annual Report on Form 10-K. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company’s expectations.
Contact: NeurologixMarc Panoff, 201-592-6451Chief Financial Officer, Treasurer and Secretarymarcpanoff@neurologix.netorKureczka/Martin AssociatesJoan Kureczka, 415-821-2413 (Media)Jkureczka@comcast.net
Posted by BooDog on :
Research Published in Science Translational Medicine Underscores Value of Depression Gene Therapy License Held by Neurologix
ShareretweetEmailPrintCompanies:Neurologix Inc. Related Quotes Symbol Price Change NRGX.OB 1.20 0.00
{"s" : "nrgx.ob","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Neurologix, Inc. On Monday October 25, 2010, 8:30 am EDT FORT LEE, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC Bulletin Board:NRGX.ob - News) today announced that a landmark paper, published on October 20th in Science Translational Medicine demonstrating the importance of the p11 gene in modulating depression in mice, utilized a gene therapy approach to reverse depression in mice for which the Company holds exclusive development rights. Based on the findings reported in the paper, gene therapy may have potential as a new treatment option for people who suffer from severe depression.
In the study, reduced levels of the p11 protein in the nucleus accumbens (NAcc) of the brain were associated with depressive behaviors in mice. An AAV vector (adeno-associated virus, a disabled, non-pathogenic virus) was used to deliver the p11 gene back into the NAcc of mice who were lacking the p11 protein, reversing the depressive behavior and returning the animals to normal function.
The study also examined samples of brain tissue from a group of deceased human patients, half of whom had severe depression. It was found that there were significantly reduced levels of p11 in the NAcc of depressed patients compared to those without depression. This further highlights the importance of this research in providing a new avenue for future treatment of this widespread disorder.
Neurologix holds the exclusive license to a patent for p11 gene therapy in the treatment of psychiatric conditions, including depression, from Cornell University for and on behalf of the Joan & Sanford I. Weill Medical College. Neurologix scientific co-founder Michael G. Kaplitt, MD, PhD, is co-inventor on the patent, and is the senior author of the research paper.
"The publication of this important research validates our decision to secure the license for developing p11 gene therapy for eventual use in people with depression and other psychiatric disorders," said Clark A. Johnson, President and Chief Executive Officer of Neurologix. "Not only do we now know more about the role of the p11 gene in depression, but Neurologix has already demonstrated results using the same transfer technology, and an effective neurosurgical approach, in our Phase 1 and Phase 2 clinical trials for NLX-P101 in patients with Parkinson's disease. We see enormous potential in developing p11 gene therapy for therapeutic use."
Neurologix's investigational gene therapy, NLX-P101, uses the same AAV technology to deliver the GAD gene (glutamic acid decarboxylase) into the subthalamic nucleus region of the brain of Parkinson's patients. Earlier this year, Neurologix disclosed top-line results of a Phase 2 clinical trial of NLX-P101, announcing that study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.
About Neurologix
Neurologix, Inc., (OTC Bulletin Board:NRGX.ob - News) is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of gene transfer therapies for serious disorders of the brain and CNS. Neurologix's therapeutic approach is built upon the groundbreaking research of its scientific founders and advisors, whose accomplishments have formed the foundation of gene therapy for neurological illnesses. The Company's current programs address such conditions as Parkinson's disease, epilepsy, depression and Huntington's disease, all of which are large markets not adequately served by current therapeutic options. For more information, please visit the Neurologix website at http://www.neurologix.net/.
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
The Company is still in the development stage and has not generated any revenues. From inception through June 30, 2010, it incurred net losses and negative cash flows from operating activities of approximately $55.7 million and $41.6 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability. At June 30, 2010, the Company had cash and cash equivalents of approximately $4.5 million. Based on its cash flow projections, the Company will need additional financing to carry out its planned business activity and to complete its plan of operations through December 31, 2010. At the Company's present level of activities, the Company's cash and cash equivalents are believed, at this time, to be sufficient to fund its operations only into the fourth quarter of 2010. Accordingly, there is substantial doubt as to the Company's ability to continue as a going concern. The Company is currently seeking to raise funds, through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, sufficient to finance its ongoing operations. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders. The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed. There is no assurance as to when, or if, the Company will be able to successfully receive approval from the FDA on its Investigational New Drug Application to commence a Phase 1 clinical trial for the treatment of epilepsy. There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing of its gene therapy for the treatment of depression or Huntington's disease to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase 1 clinical trial or that, if filed, such permission will be granted.
Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information about factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2009 Annual Report on Form 10-K. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations.
Contacts: Neurologix
Marc Panoff, 201-592-6451
Chief Financial Officer
marcpanoff@neurologix.net
Related Headlines Research Published in Science Translational Medicine Underscores Value of Depression Gene Therapy License Held by Neurologix - PR Newswire Gene Therapy for Depression May Head to Human Tests - Bloomberg NEUROLOGIX INC/DE Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits - EDGAR Online New Details Presented at the World Parkinson Congress on Neurologix's Successful Phase 2 Trial of Gene Therapy for Parkinson's Disease - PR Newswire Small Cap Biotech Stocks: 7 Picks, 1 Big Concern - at Seeking Alpha
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