Research Published in Science Translational Medicine Underscores Value of Depression Gene Therapy License Held by Neurologix
FORT LEE, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC Bulletin Board: NRGX) 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.
Neurologix, Inc., (OTC Bulletin Board: NRGX) 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.
Cautionary Statement Regarding Forward-Looking Statements
This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
- The Company is still in the development stage and has not generated any revenues. From inception through 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.
Marc Panoff, 201-592-6451
Chief Financial Officer
SOURCE Neurologix, Inc.
Posted: October 2010