CELL GENESYS INITIATES SECOND PHASE III TRIAL OF GVAX

Cell Genesys has initiated a second multicenter Phase III clinical trial of its GVAX vaccine for prostate cancer in patients with metastatic hormone-refractory prostate cancer.

This second Phase III trial, referred to as VITAL-2, is the other key component of the company's product registration strategy that builds on promising findings from two previously reported Phase II trials of the vaccine in over 100 patients with advanced prostate cancer. The trial will compare GVAX for prostate cancer plus Taxotere (docetaxel) chemotherapy to Taxotere plus prednisone with respect to survival benefit. The study is expected to enroll approximately 600 patients at approximately 100 medical centers across North America and Europe.

In May 2005, Cell Genesys received a special protocol assessment from the FDA for the trial, which provided FDA confirmation that the trial design would adequately support a product registration application.