Ceregene Licenses Genes From Genentech for Neurological Gene Therapies
Wednesday March 26, 7:01 am ET
Exclusive License Covers Gene Therapies for Alzheimer's Disease and Other Neurological Disorders
SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- Ceregene, Inc., a biotechnology company focused on gene therapies for neurological disorders, has signed a licensing agreement with Genentech, Inc. (NYSE: DNA - News) for exclusive worldwide rights to genes expressing two nervous system growth factors for use in neurological gene therapies using certain viral vectors. These patented neurotrophic factor genes, coding for the proteins known as nerve growth factor (NGF) and neurotrophic factor 4/5 (NT-4/5) have demonstrated therapeutic potential in the treatment of neurodegenerative disorders, among other applications. The naturally occurring NGF gene encodes the NGF protein that maintains survival of nerve cells in the brain that are required for memory, and is the gene being delivered in Ceregene's lead clinical program for Alzheimer's disease. Ceregene similarly intends to develop the NT-4/5 gene as a neuroprotective agent. Genentech has an option to become Ceregene's development and marketing partner for NT-4/5 gene therapy upon completion of Phase II clinical studies, after paying Ceregene an opt-in fee and milestone payments. Financial terms were not disclosed.
Neurotrophic factors have been widely studied for their potential to treat a range of diseases. Ceregene is currently developing products to deliver genes encoding certain neurotrophic factors to the specific target sites in the brain where they offer the greatest therapeutic benefit. Ceregene's founders have worked with NGF and other neurotrophic factors in extensive preclinical gene therapy studies to demonstrate their therapeutic potential. The company has exclusive rights to technology that is being used in an ongoing, fully enrolled, Phase I clinical trial of NGF gene therapy in Alzheimer's disease involving eight patients, which is being conducted at the University of California, San Diego (UCSD), delivering NGF to Alzheimer's disease patients using gene therapy techniques. All patients have completed treatment, and patients are now being monitored for improvement in their disease using cognitive function and brain imaging. Preliminary results from this trial indicate that the gene therapy treatment is well tolerated and biologically active. A complete report on this trial is expected later in 2003.
"This agreement is a significant milestone in the development of Ceregene's lead product, NGF gene therapy for Alzheimer's disease," stated Jeffrey M. Ostrove, Ph.D., president and chief operating officer of Ceregene. "We are pleased to have the opportunity to leverage Genentech's high-caliber research."
"Today, Alzheimer's disease represents a major unmet medical need, and current therapies are limited to drugs that attempt to restore the function of specific nerves by increasing the levels of certain chemical messengers in the brain," stated Raymond T. Bartus, Ph.D., vice president, research and development of Ceregene. "Our NGF strategy is attempting to prevent the deterioration of these same specific nerves referred to as cholinergic neurons."
About Ceregene
Ceregene, Inc. is a San Diego-based biotechnology company focused on the development and commercialization of gene therapies for neurological disorders including Alzheimer's disease and Parkinson's disease. Ceregene was launched in January 2001 and is a majority-owned subsidiary of Cell Genesys, Inc. (Nasdaq: CEGE - News), which is headquartered in South San Francisco, CA.
Statements made herein about Ceregene and Cell Genesys, other than statements of historical fact, including statements about product pipelines, license agreements and clinical and preclinical programs including those dealing with licensed neurotrophic factor genes are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made including risks associated with the success of research and development programs, clinical trials, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of licensing agreements including the agreement with Genentech and the need for additional financings. For information about these and other risks which may affect Ceregene and Cell Genesys, please see the Cell Genesys Annual Report on Form 10-K dated April 1, 2002 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.
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Source: Ceregene, Inc. |
