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Neurologix Completes Procedures in Landmark Phase I Gene Therapy Trial; Co-Founder Presents Trial Update at Parkinson's Disease Conference
Wednesday, June 08, 2005
FORT LEE, N.J. (Business Wire) -- Neurologix, Inc. (OTCBB:NRGX), today announced the completion of all neurosurgical gene transfer procedures in its landmark, 12-patient, dose-escalating Phase I clinical trial of gene therapy for Parkinson's disease. The Company also announced that its co-founder Michael Kaplitt, M.D., Ph.D. presented an update on the trial at the 16th International Congress on Parkinson's Disease and Related Disorders in Berlin on June 7, 2005. Dr. Kaplitt, who performed the procedure on all 12 patients at the New York Weill Cornell Medical Center, co-chaired the "Hot Topics: Treatment" session and delivered a presentation entitled "First clinical trial of gene therapy for Parkinson's disease."
The Neurologix trial is the world's first in which a virus was injected directly into the brain to transfer a gene to treat Parkinson's disease. During his presentation Dr. Kaplitt reported all patients underwent the surgical gene transfer procedure while awake and under only local anesthesia. All patients were discharged from the hospital within 48 hours. There has been no evidence of any treatment-related adverse effects to date. Patients have now been followed from one to 22 months post procedure.
"The primary outcome measure of a Phase I trial is safety and we are pleased that we have been able to meet that threshold so far," said Michael Sorell, M.D., CEO of Neurologix. "The fact that there were no complications associated with the procedure brings us a step closer to our ultimate goal. We now plan to formulate and implement the requisite additional clinical trials."
Dr. Michael Kaplitt commented, "It has always been our belief that demonstrating safety of viral gene therapy of the brain would establish a new platform of medical technology. We are encouraged by our results to date, which have important implications for our many evolving gene therapy strategies, and we are hopeful that this specific therapy will prove not only safe, but effective against Parkinson's disease."
Neurologix also noted that at the Berlin conference, Nobel Laureate Paul Greengard, the chairman of its Scientific Advisory Board, gave the keynote address at the opening ceremonies of the meeting and Dr. David Eidelberg, authored a paper on neuroimaging. Dr. Eidelberg, along with his colleague Dr. Andrew Feigin of the North Shore Hospital Long Island Jewish Movement Disorder Clinic are monitoring, evaluating and reviewing our patients neurologically before and for one year after the gene transfer procedure.
About Neurologix
Neurologix, Inc. is a development-stage company, which through its subsidiary, Neurologix Research, Inc., is engaged in the research and development of proprietary treatments for disorders of the brain and central nervous system primarily utilizing gene therapies. The Company's initial development efforts are focused on gene therapy for treating Parkinson's disease and epilepsy and its core technology, which it refers to as "NLX," is currently being tested in a Company-sponsored Phase I human clinical trial to treat Parkinson's disease.
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," "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 March 31, 2005, it has incurred net losses and negative cash flows from operating activities of $9.7 million and $8.2 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.
-- If the ongoing Phase I clinical trial for treatment of Parkinson's disease using the Company's NLX technology is unsuccessful, future operations and the potential for profitability will be significantly adversely affected and the business may not succeed.
-- Since the Company's existing resources will not be sufficient to enable the Company to obtain the regulatory approvals necessary to commercialize its current or future product candidates, it will need to raise additional funds through public or private equity offerings, debt financings or additional corporate collaboration and licensing arrangements. Availability of financing depends upon a number of factors beyond the Company's control, including market conditions and interest rates. 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.
-- 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 epilepsy to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase I safety 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 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 2005 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.
Neurologix, Inc.
Michael Sorell, 201-592-6451
www.neurologix.net
or
Lippert/Heilshorn & Associates, Inc. (Investor Relations)
Kim Sutton Golodetz / Shayne Payne, 212-838-3777
kgolodetz@lhai.com / spayne@lhai.com
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