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Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
Date:2/15/2008

tere(R) (docetaxel) chemotherapy plus prednisone in HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. An interim analysis of the trial was recently conducted by an independent data monitoring committee in the timeframe originally estimated and resulted in the recommendation to continue the trial. The company expects to have enough events to trigger the final analysis of VITAL-1 in the second half of 2009. VITAL-2, which the company expects to fully enroll with approximately 600 patients in the first half of 2009, is designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in HRPC patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial is also an improvement in survival. The company expects to have enough events to trigger an interim analysis of VITAL-2 in the first half of 2009.

About GVAX Cancer Immunotherapies

GVAX cancer immunotherapies are non patient-specific investigational products comprised of whole tumor cells that have been modified to secrete GM- CSF (granulocyte-macrophagecolony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX is administered via intradermal injections on an outpatient basis. To date, over 600 patients have been treated with GVAX cancer immunotherapies in Phase 1 and Phase 2 clinical trials for multiple indications, including prostate cancer, pancreatic cancer, and leukemia. The company is currently manufacturing GVAX immunotherapy for prostate cancer in its bioreactor-based manufacturing plant in Hayward, California, a facility that is also capable of manufacturing the product for commercialization.

About Cell Genesys

Cell Genesys is focused on the development and comme
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