�Neurologix, Inc. (OTCBB:NRGX), a biotechnology troupe engaged in the development of innovative gene therapies for the brain and central neural system, announced 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 glide slope 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.
The randomized, double-blind, sham-procedure controlled tryout will involve up to 10 in the lead academic enquiry centers crossways 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 handling bilaterally via a catheter temporarily placed in each subthalamic nucleus (STN) (a deep brain structure that is the main target of operating room to treat Parkinson's disease) by stereotactic surgery. The other 20 participants will receive aseptic 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 standardised Parkinson's disease ratings at multiple time points post-procedure. The main endpoint for the study will be a clinical assessment of motor office at 6 months victimisation the Unified Parkinson's Disease Rating Scale (UPDRS). All participants in the study will too be monitored for base hit for 12 months following the cistron transfer operation. If the primary end point 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 transpose therapy if they continue to adjoin all accounting entry, medical and surgical criteria.
"Parkinson's disease is a devastating sickness for those patients whose symptoms are no longer well controlled by medication alone," aforementioned 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 reproducible with the brain's normal metabolic activity."
For inside information about participating in the clinical trial, please see here.
About the Neurologix Gene Transfer Approach to Parkinson's Disease
In Parkinson's disease, patients lose dopamine-producing brain cells, which results in significant reductions in the natural process and sum of money of GABA (gamma-aminobutyric acid), a major inhibitory neurotransmitter in the brain that helps 'quiet' excessive neuronic firing. This reduction in GABA causes a disfunction in encephalon circuitry responsible for coordinating movement. GABA is made by a gene called glutamic caustic decarboxylase, or GAD.
Neurologix's gene transfer approach to Parkinson's disease seeks to restore GABA -- and thus better the patient's motor ascendency -- by inserting the GAD factor back into an area of the brain called the subthalamic nucleus, a key regulative center for movement.
About Neurologix
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotech company consecrated to the discovery, growth, and commercialisation of life-altering gene transplant therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's healing 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 ar large markets not adequately served by current alterative options. For more information, please visit the Neurologix website at http://www.neurologix.net.
Cautionary Statement Regarding Forward-looking Statements
This news release includes sure statements of the Company that whitethorn constitute "forward-looking statements" inside the import 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 ar based upon the beliefs of direction and assumptions made by and entropy currently usable 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 historic fact. When used in this text file, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, ar 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 grounds the existent results, performance or achievements of the Company to be materially different from any future results, public presentation or achievements that may be expressed or implied by such forward-looking statements, including, only not special to, the following:
- The Company is still in the development stage and has non generated whatsoever revenues. From inception through June 30, 2008, it incurred net losses and negative cash flows from operating activities of some $31.3 million and $25.0 million, severally. Management believes that the Company volition continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may accept years to develop, test and find regulatory favourable reception for a gene-based therapy product ahead it tin can be sold, the Company likely will continue to incur important losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitableness.
- At June 30, 2008, the Company had cash and johnny Cash equivalents of approximately $21.6 million, which management believes testament be sufficient to fund the Company's operations through at least December 31, 2009. The Company does not know whether additional financing testament be uncommitted when needed, or if available, testament 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 victimisation the Company's NLX engineering. If the trials prove unsuccessful, future operations and the potential for profitableness will be materially adversely affected and the business may non 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 start up a Phase 1 clinical trial for the discussion of epilepsy.
Other factors and assumptions not identified above could also causal agency the literal results to differ materially from those set away in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is launch in the section nges in the Company's expectations.
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