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Michael J. Fox Foundation Announces Funding for Ceregene Phase-1 Gene Therapy Clinical Trial

Posted on: Monday, 28 November 2005, 15:00 CST

NEW YORK, Nov. 28 /U.S. Newswire/ -- The Michael J. Fox Foundation for Parkinsonbs Research (MJFF) today announced a three- year grant of approximately $740,000 to Ceregene, Inc., a San Diego- based biotechnology company. The grant will help fund Ceregenebs Phase I clinical study of CERE-120, a novel gene therapy product that has shown potential in pre-clinical testing to slow or stop the progression of Parkinsonbs disease by using a vector to deliver neurturin, a potent nervous system growth factor.

While the primary goal of any Phase I clinical study is to demonstrate safety, Ceregene will also measure the efficacy of CERE- 120 through brain imaging studies and standardized Parkinsonbs tests. MJFF support will significantly enhance the speed and depth of this data collection, allowing for more regular testing of a wider range of neurological functions than would otherwise be possible. Each patient will undergo a PET scan and a full battery of neurological tests every three months (in addition to regular visits to the clinic for more routine procedures such as blood tests). Assuming successful results in the first study, measurements from the Phase I study will lead to more efficient planning of a larger Phase II study that will gather more detailed data on both safety and efficacy.

"The Phase I trial of CERE-120 brings several Foundation priorities to bear," said Deborah W. Brooks, MJFF president and CEO. "These include investigating the neurorestorative properties of neurotrophic factors, advancing translational research, and shortening the time it takes to turn basic research advances into meaningful therapies for patients." She added that without Foundation support, the trial would proceed at a slower pace, with fewer clinical assessments and less imaging -b resulting in longer timelines to completion.

"Webre pleased to have Fox Foundation support to optimize our clinical tests of CERE-120," said Jeffrey M. Ostrove, Ph.D., president and CEO of Ceregene. "This funding will allow us to gather, in the shortest time possible, the data needed to know if we are on to a safe therapy that might slow or stop the progression of the disease b- something no treatment on todaybs market can do."

Neurotrophic factors, also known as growth factors, have long been considered one of the most promising avenues for Parkinsonbs therapies, as they promote survival and improve function of neurons. Neurturin is a member of the same protein family as GDNF (glial- derived neurotrophic factor), which has previously been tested in people with Parkinsonbs, and the two have similar pharmacological properties: Both maintain survival of the dopamine-producing nerve cells that are required for normal bodily movement and that degenerate in people with Parkinsonbs.

"Extensive studies in animal models, including the most widely accepted models of Parkinsonbs disease, have consistently demonstrated that CERE-120 is safe and well tolerated in animals even at doses hundreds of times higher than the equivalent doses being tested in humans. These studies also demonstrate that CERE- 120 may be able to improve symptoms as well as slow the progression of Parkinsonbs disease," stated Raymond T. Bartus, Ph.D., Ceregenebs COO and principal investigator on the grant.

The MJFF funding supplements Ceregenebs own multi-million dollar investment in the study, which is under way at the University of California, San Francisco Medical Center and Rush University Medical Center in Chicago.

Other MJFF investments in neurotrophic factors to date include a current LEAPS (Linked Efforts to Accelerate Parkinsonbs Solutions) project investigating encapsulated cell technology as a delivery mechanism for GDNF and two Community Fast Track 2004 projects: One evaluated two proteins from the neuregulin family of growth factors as a potential therapeutic agents in animal models, and another examined a molecule called pleiotrophin as a potential neuroprotective/restorative agent for dopamine neurons in animal models.

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About Ceregene:

Ceregene, Inc. is a San Diego-based biotechnology company focused on the development of gene therapies for neurodegenerative disorders. Ceregene is in the clinic with CERE-110, an AAV2 based vector expressing nerve growth factor that is being tested as a treatment for Alzheimerbs disease, and CERE-120 for Parkinsonbs disease. Ceregene was launched in January 2001 and is a former subsidiary of Cell Genesys, Inc. (NASDAQ: CEGE), which is headquartered in South San Francisco, CA. Ceregenebs investors include Alta Partners, MPM Capital and Cell Genesys, as well as Hamilton BioVentures and California Technology Partners.

About The Michael J. Fox Foundation:

Founded in 2000, The Michael J. Fox Foundation for Parkinsonbs Research is dedicated to ensuring the development of a cure for Parkinsonbs disease within this decade through an aggressively funded research agenda. The Foundation has funded approximately $56 million in research to date, either directly or through partnerships.

http://www.usnewswire.com

Source: U.S. Newswire

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