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Interim Analysis Supports Continuation of Cell Genesys' VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
Date:1/14/2008

America and Europe.

The company's second Phase 3 trial, VITAL-2, is a multi-center, randomized, controlled Phase 3 clinical trial 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. VITAL-2 was initiated in June 2005 and is currently enrolling patients at approximately 90 sites in North America and Europe. The company expects to complete enrollment of approximately 600 patients in the first half of 2009 and if this is achieved, to have a sufficient number of events for a pre-planned interim analysis at that time.

The U.S. Food and Drug Administration (FDA) granted Cell Genesys Special Protocol Assessments (SPAs) for both VITAL-1 and VITAL-2. The SPA is a process that allows for official FDA evaluation of a Phase 3 clinical trial and provides trial sponsors with a binding written agreement that the design and analysis of the study are adequate to support a license application submission if that study is performed according to the SPA. Cell Genesys completed the modifications requested by FDA during the review process.

About GVAX Cancer Immunotherapies

GVAX cancer immunotherapies are non patient-specific investigational therapeutics comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and then irradiated for safety. GVAX is designed to be administered through 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 GV
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SOURCE Cell Genesys, Inc.
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