Cell Genesys Receives SPA From FDA for Second Phase III Trial of GVAX

May 23, 2005

Cell Genesys has received a special protocol assessment (SPA) from the FDA for its second Phase III clinical trial of GVAX vaccine for prostate cancer.

The SPA is a process that allows for official FDA evaluation of a Phase III clinical trial and provides trial sponsors with binding written agreement that the design and analysis of the study are adequate to support a license application submission if the study is performed according to the SPA. The company's first Phase III trial of GVAX vaccine for prostate cancer was initiated in July 2004 and was also granted a SPA by the FDA.