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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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scottie says news on the way. Been getting some jiggles. Still pretty low volumes though.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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“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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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posted
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
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
| IP: Logged |
posted
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
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
| IP: Logged |
posted
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
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KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Genetics
Pharmaceutical
Research
Science
SUBJECT CODE: Contract/Agreement
Source: Comtext Market News
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* ######## = 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
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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
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KEYWORD: United States
North America
New Jersey
INDUSTRY KEYWORD: Health
Biotechnology
Clinical Trials
&n bsp; Mental Health
Pharmaceutical
Research
Science
Source: Comtext Market News
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May want to watch Frontline on PBS tomorrow at 9pm. A story about Parkinsons.
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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
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< 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
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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:
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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
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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.
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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.
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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
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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
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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.”
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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
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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.
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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
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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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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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
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-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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