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Author Topic: NRGX Gene therapy
BooDog
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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.

http://www.neurologix.net

NEUROLOGIX INC at C.E. Unterberg, Towbin Emerging Growth Conference
Tuesday, July 10, 2007 4:30 p.m. ET

http://www.wsw.com/webcast/ceut6/register.aspx?conf=ceut6&page=nrgx&url=http%3A/ /www.wsw.com/webcast/ceut6/nrgx/

Fact sheet:
http://media.corporate-ir.net/media_files/irol/10/106413/NRGXFactSheet1.pdf


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.

filings

http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000356591&owner=i nclude&count=40-----------


my other thread from the hotstocks section
http://www.allstocks.com/stockmessageboard/ubb/ultimatebb.php/ubb/get_topic/f/2/ t/014279/p/1.html#000000

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…

http://www.fool.com/investing/general/2004/08/02/whats-a-drug-worth.aspx

http://www.biogeneticventures.com/news/feature2.pdf

http://www.maricopa.edu/bwd/pdfs/biotechpb.pdf
------------------------------------------------------------


NEUROLOGIX INC (OTC BB:NRGX.OB)

Last Trade: 1.14
Trade Time: 3:59PM ET
Change: 0.02 (1.72%)
Prev Close: 1.16
Open: 1.20
Bid: 1.13 x 500
Ask: 1.17 x 500
1y Target Est: N/A

Day's Range: 1.14 - 1.20
52wk Range: 0.45 - 4.50
Volume: 37,500
Avg Vol (3m): 59,313.9
Market Cap: 30.26M
P/E (ttm): N/A
EPS (ttm): -0.40
Div & Yield: N/A (N/A)


 -

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BooDog
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http://video.google.com/videoplay?docid=-7439171952665148194

research diversion tool.

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BooDog
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Took him down from 1.14 to 1.11 pretty easy.
printed 1.19

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BooDog
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Some history with The Michael J. Fox Foundation

http://www.michaeljfox.org/newsEvents_mjffInTheNews_article.cfm?ID=97


June, 22 2007
http://www.michaeljfox.org/newsEvents_parkinsonsInTheNews_article.cfm?ID=211

June 22, 2007

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.

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BooDog
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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

Day's Range: 1.19 - 1.25
52wk Range: 0.45 - 4.50
Volume: 5,500
Avg Vol (3m): 57,044.7
Market Cap: 33.18M
P/E (ttm): N/A
EPS (ttm): -0.40
Div & Yield: N/A (N/A)


9mm cash on hand
expenses are about 500k / qtr

--------------------
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BooDog
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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

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BooDog
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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

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BooDog
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should touch back on the 200 around .91 thinking in the next couple weeks. Looking for .85.

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BooDog
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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

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10of13
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Bump...

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#1 Rule: Protect your capital! #2 Rule: Never fall for the BS on the boards!

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BooDog
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quote:
Originally posted by 10of13:
Bump...

[Big Grin] Cheers 10!! [Big Grin]

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BooDog
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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."


http://biz.yahoo.com/bw/071109/20071109005075.html?.v=1

Didn't see it on edgar yet but should be soon.

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BooDog
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http://www.sec.gov/Archives/edgar/data/356591/000119380507002800/e602792_10qsb-n eurologix.htm

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BooDog
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http://www.myparkinsons.org/parkinsons-disease-caregiver-news.shtml


http://www.therubins.com/illness/Parkinson.htm

http://www.myparkinsonsinfo.com/

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BooDog
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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.

Cautionary Statement Regarding Forward-looking Statements

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

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BooDog
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Check this out...

By NIDHI THAREJA, M.D.
ABC News Medical Unit
Nov. 20, 2007
Font Size

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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.

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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."

http://www.michaeljfox.org/newsEvents_parkinsonsInTheNews_article.cfm?ID=270

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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.

http://www.cnn.com/2007/HEALTH/11/20....ap/index.html

'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

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BooDog
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convertibles updated.
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000356591&owner=i nclude&count=40

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up .09 low volume but nice itty bitty spike. lol

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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.

Cautionary Statement Regarding Forward-looking Statements

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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All post are my opinion. Do your own DD. Who's clicking your buy/sell button!?

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BooDog
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printed 1.25 [Big Grin]

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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

Day's Range: 0.96 - 1.25
52wk Range: 0.45 - 4.50
Volume: 30,580
Avg Vol (3m): 16,403.1
Market Cap: 33.35M
P/E (ttm): N/A
EPS (ttm): -0.28
Div & Yield: N/A (N/A)

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All post are my opinion. Do your own DD. Who's clicking your buy/sell button!?

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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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All post are my opinion. Do your own DD. Who's clicking your buy/sell button!?

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BooDog
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yawn...

TGIF

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BooDog
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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.

Cautionary Statement Regarding Forward-looking Statements

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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BooDog
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[Big Grin] [Big Grin] [Wink]

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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

-------------------------------------------

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….

-------------------------------------------

Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research
Tuesday December 4, 8:31 am ET

http://biz.yahoo.com/bw/071204/20071204005173.html?.v=1

…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….
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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.

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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.

Cautionary Statement Regarding Forward-looking Statements

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: NeurologixMarc Panoff, 201-592-6451Chief Financial Officer, Treasurer and Secretarymarcpanoff*neurologix.netorKureczka/Martin AssociatesJoan Kureczka, 415-821-2413 (Media)jkureczka*comcast.net


Copyright Business Wire 2007

-0-


KEYWORD: United States

North America

New Jersey

INDUSTRY KEYWORD: Health

Biotechnology

Clinical Trials

Genetics

Pharmaceutical

Research

FDA

Science

SUBJECT CODE: Product/Service

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1.20

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1.25

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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%)
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Day's Range: N/A - N/A
52wk Range: 0.60 - 4.50
Volume: 0
Avg Vol (3m): 16,381
Market Cap: 29.58M
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EPS (ttm): -0.28
Div & Yield: N/A (N/A)

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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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All post are my opinion. Do your own DD. Who's clicking your buy/sell button!?

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