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Future Clinical Trials for GVAX Lung Cancer Vaccine

The GVAX lung cancer vaccine trials to date, including the current study, have employed a patient-specific product format in which the vaccine is directly prepared from the patients own tumor cells in an overnight process. In the near future, Cell Genesys plans to launch a clinical trial in advanced lung cancer to evaluate a non patient-specific GVAX product which will be centrally manufactured by Cell Genesys and then mixed with patients own irradiated tumor cells prior to vaccination. This new product format for GVAX lung cancer vaccine is expected to have significant development and commercialization advantages compared to the first generation product used in the trial reported today. Given the encouraging results demonstrated in ongoing clinical trials for prostate and pancreatic cancer, Cell Genesys is emphasizing non patient-specific GVAX products which can be developed and commercialized as off-the-shelf pharmaceuticals.

Background on GVAX Cancer Vaccines

GVAX cancer vaccines are comprised of tumor cells which have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor. The company's lead GVAX cancer vaccine program targets patients with recurrent hormone refractory prostate cancer and is currently being evaluated in two multicenter Phase II trials. A series of Phase I/II trials was recently initiated utilizing the companys new high-potency GVA
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Contact: Todd Ringler
tringler@fkhealth.com
617-761-6791
Feinstein Kean Healthcare
12-May-2001