Press Releases
03/26/03
Ceregene Licenses Genes From Genentech For Neurological Gene Therapies
Exclusive License Covers Gene Therapies for Alzheimers Disease and Other Neurological Disorders
SAN DIEGO, CA, March 26, 2003—Ceregene, Inc., a biotechnology company focused on gene therapies for neurological disorders, has signed a licensing agreement with Genentech, Inc. (NYSE: DNA) 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 Ceregenes lead clinical program for Alzheimers 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. Ceregenes 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 Alzheimers disease involving eight patients, which is being conducted at the University of California, San Diego (UCSD), delivering NGF to Alzheimers 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 Ceregenes lead product, NGF gene therapy for Alzheimers disease," stated Jeffrey M. Ostrove, Ph.D., president and chief operating officer of Ceregene. "We are pleased to have the opportunity to leverage Genentechs high-caliber research."
"Today, Alzheimers 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."
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), which is headquartered in South San Francisco, CA.