Mar. 15, 2010 (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.
Cautionary Statement Regarding Forward-Looking Statements
This news release includes certain statements of the Company that may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements and other information relating to the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words “expects,” “promises,” “anticipates,” “estimates,” “plans,” “intends,” “projects,” “predicts,” “believes,” “may” or “should,” and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company’s management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following:
- The Company is still in the development stage and has not generated any revenues. From inception through September 30, 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.
