Cell Genesys GVAX second pivotal begins
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cell Genesys is initiating a second Phase III trial of its therapeutic prostate cancer vaccine GVAX, the firm says July 5. The VITAL-2 study in patients with metastatic hormone-refractory prostate cancer "is the other key component of the company's product registration strategy." The other pivotal trial, VITAL-1 , is still enrolling. VITAL-2 will compare GVAX plus Sanofi-Aventis' Taxotere to Taxotere plus prednisone; VITAL-1 is looking at GVAX vs. Taxotere/prednisone. Both trials are designed to show superiority with respect to survival. VITAL-1 is being conducted under a special protocol assessment with FDA (1Pharmaceutical Approvals Monthly May 2004, p. 5)...