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www.fdanews.com/articles/72559-cell-genesys-reports-positive-follow-up-data-from-trial-of-gvax-vaccine

Cell Genesys Reports Positive Follow-Up Data From Trial of GVAX Vaccine

May 20, 2005

Cell Genesys has reported additional results from its second multicenter Phase II trial of GVAX vaccine for prostate cancer which evaluated escalating doses of the vaccine in 80 patients with advanced hormone-refractory metastatic prostate cancer.

The results to date for the 22 patients who received the highest dose -- the dose which is currently being employed in the company's ongoing Phase III trial -- indicate that the median survival has not been reached for this group of patients and that the final median survival will be no less than 24.1 months based on the current median follow-up time for these patients.

Previously reported findings from the company's first multicenter Phase II trial of GVAX vaccine for prostate cancer indicated an overall median survival of 26.2 months in a similar group of patients, a result that compares favorably to the recently reported median survival of 18.9 months for hormone-refractory metastatic prostate cancer patients treated with Taxotere plus prednisone.

The company's ongoing Phase III clinical trial is a randomized, controlled comparison of GVAX vaccine for prostate cancer and Taxotere plus prednisone with respect to survival benefit.