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Neurologix Licenses Promising New Gene for Treatment of Alzheimer's and Other CNS Disorders

Posted on: Wednesday, 18 May 2005, 06:00 CDT

Neurologix, Inc. (OTCBB:NRGX), 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 (CNS) primarily utilizing gene therapies, today announced that it has licensed the humanin gene from Keio University in Tokyo Japan as part of a strategic move to broaden its product portfolio. The license agreement provides Neurologix with exclusive worldwide rights (excluding Japan) to develop and commercialize therapeutics to treat brain and other CNS disorders (excluding Amyotrophic Lateral Sclerosis) using the humanin gene.

The humanin gene will be used in combination with Neurologix's proprietary gene transfer technology. The resulting therapeutic is expected to be the Company's lead compound for a novel and promising approach to Alzheimer's disease.

Humanin, a 24 amino acid peptide, was identified by Dr. Ikuo Nishimoto and colleagues at Keio University by screening for novel genes that prevent the amyloid toxicity associated with Alzheimer's disease as reported in the Proceedings of the National Academy of Sciences in 2001.(1) The peptide is secreted, binds to the receptor on the cell membrane and then acts potently through parallel mechanisms to inhibit cell death pathways active in Alzheimer's disease and other neurodegenerative disorders. Humanin is of specific interest because it appears to be one of the body's internal anti-Alzheimer's defenses, and it is specifically found in brain regions that are naturally resistant to Alzheimer's disease.

Further independent characterization of the mechanism of action for humanin was reported in follow-up studies by Dr. J.C. Reed and colleagues of the Burnham Institute, La Jolla, Calif. as published in Nature in 2003.(2) Additional confirmation by the same group was published in the Journal of Biological Chemistry in 2005.(3)

"We believe that humanin, as a secreted protein, is specifically well-suited for gene therapy applications because a therapeutic could be readily delivered into the cerebrospinal fluid. This could lead to persistent and efficient delivery of the therapeutic without the need for brain surgery or repeated injections," commented Michael Sorell, M.D., chief executive officer of Neurologix. "We are proposing an aggressive, fast-track development for humanin."

"Neurologix has an active preclinical program in neurodegenerative disorders and we believe that the humanin project will complement our ongoing clinical Parkinson's disease and Epilepsy programs. In our landmark gene therapy clinical trial for Parkinson's disease, we have shown that we can safely deliver genes directly to specific target areas of the brain to effect treatment. With this effective delivery know-how, we hope to unlock the potential of humanin and develop effective gene therapeutics to treat a variety of brain and other CNS disorders, including Alzheimer's disease," Dr. Sorell continued.

Alzheimer's disease is a devastating disorder of the brain's nerve cells that impairs memory, thinking, and behavior and leads, ultimately, to death. According to data compiled by the Alzheimer's Association (AA), an estimated 4.5 million Americans have Alzheimer's disease, a number which has more than doubled since 1980. National direct and indirect annual costs of caring for individuals with Alzheimer's disease are at least $100 billion, according to estimates used by the AA and the National Institute on Aging. The impact of Alzheimer's on individuals, families and our health care system makes the disease one of our nation's greatest medical, social and fiscal challenges, according to the AA.

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. -0- *T (1)Hashimoto Y et al., (2001) A rescue factor abolishing neuronal cell death by a wide spectrum of familial Alzheimer's disease genes and Abeta. Proc Natl Acad Sci U S A. 98, 6336-41 (2)Guo B, Zhai D, Cabezas E, Welsh K, Nouraini S, Satterthwait AC, Reed JC. (2003) Humanin peptide suppresses apoptosis by interfering with Bax activation. Nature 423, 456-461 (3)Luciano F, Zhai D, Zhu X, Bailly-Maitre B, Ricci JE, Satterthwait AC, Reed JC. (2005) Cytoprotective peptide humanin binds and inhibits proapoptotic Bcl-2/Bax family protein BimEL. J Biol Chem. 280, 15825-35 *T

Source: Business Wire

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