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[QUOTE]Originally posted by BooDog: [QB] 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.” For details about participating in the clinical trial, please visit http://clinicaltrials.gov/ct2/show/NCT00643890?term=neurologix&rank=1. 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. 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, 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. [/QB][/QUOTE]
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