Article: Cell Genesys Receives GVAX SPA For Phase III Prostate Cancer Trial.

Staff Writer

Paving its way for an eventual biologics license application, Cell Genesys Inc. received a special protocol assessment from the FDA for its upcoming Phase III trial of the GVAX prostate cancer vaccine.

The South San Francisco-based company plans to begin the trial, the first of two, at the end of the second quarter.

"We expect to enroll somewhere in the neighborhood of 500 to 600 patients in the study," said Jennifer Cook Williams, director of corporate communications and investor relations for Cell Genesys. "The endpoint will be survival and there will be a complementary trial, which we hope to start in late 2004 or early 2005."

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