Neurologix Completes All Surgical Procedures in Its Clinical Trial for Parkinson's Disease
FORT LEE, N.J. - (Business Wire) Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, announced the completion of all planned surgeries in an ongoing Phase 2 clinical trial of the company's gene transfer approach to the treatment of advanced Parkinson's disease. The controlled, double blinded, 44 patient Phase 2 trial is investigating the safety and efficacy of a novel non-dopamine approach to restore motor function in Parkinson's patients who are sub-optimally responsive to available drug therapy. The company expects to announce initial efficacy results from the trial in mid-2010.
The investigators are assessing each of the trial participants over time for treatment effects, with the primary trial endpoint being a clinical assessment of motor 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 their gene transfer procedure.
"We are very pleased the trial sites have completed all of the surgical procedures for this important study," said John Mordock, President and Chief Executive Officer of Neurologix. "This represents a significant milestone in the development of a potential new treatment option for the greatly underserved population of patients with advanced Parkinson's disease."
All surgical procedures were performed at the following institutions: Henry Ford Health System, Massachusetts General Hospital, The Ohio State University, Stanford University, University of Colorado, University of Rochester and Wake Forest University Health Sciences.
Mr. Mordock commented, "We are extremely grateful to the patients, physicians and institutions for their strong support in reaching this milestone in a timely fashion, and we look forward to getting our initial look at efficacy from the trial around mid 2010.
"In anticipation of the continued development of this new therapeutic approach," he continued, "we are now making preparations for a Phase 3 clinical trial, which we will seek to conduct under a Special Protocol Assessment (SPA)."
Mr. Mordock noted that Neurologix's gene therapy approach to Parkinson's aims to provide a safer and more effective alternative to either dopamine replacement therapies or deep brain stimulation for patients with advanced stages of the disease. Neurologix's strategy is to deliver a gene ("GAD") that reestablishes the production of GABA (gamma-aminobutyric acid), the major brain inhibitory neurotransmitter that helps "quiet" excessive neuronal firing. Scientists have determined this neurotransmitter to be deficient in the brains of patients in the advanced stages of Parkinson's disease.
"Our Phase 1 clinical trial demonstrated an encouraging improvement in clinical symptoms of Parkinson's disease along with a reduction in abnormal brain function as demonstrated through PET imaging," Mr. Mordock noted. "We are hopeful that this larger, Phase 2 treatment trial may further demonstrate our approach to be effective for improving motor symptoms and brain function in late-stage Parkinson's disease patients while avoiding the further surgical risks and limitations of deep brain stimulation and the complications associated with over-production of dopamine often associated with currently used pharmacologics. If successfully developed, this gene transfer procedure could become the first significant advance for patients with late-stage Parkinson's disease since the introduction of deep brain stimulation."
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.
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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 by December 31, 2009 or shortly thereafter, 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.