Cell Genesys Reports Median Survival Data From Prostate Cancer Study

Cell Genesys has announced the final results of its second multicenter, Phase II trial of GVAX immunotherapy for prostate cancer, which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer.

Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase III program indicates that the median survival is 35 months. The company previously reported median survival results from its first Phase II trial of GVAX in 34 patients with metastatic hormone-refractory prostate cancer that showed an overall median survival of 26.2 months.

The survival results from the two trials compare favorably with the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company's ongoing Phase III program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.

"We are certainly encouraged by the survival data from the second Phase II trial of GVAX immunotherapy for prostate cancer," Rob Dow, chief medical officer of Cell Genesys, said. "We continue to hope that GVAX immunotherapy for prostate cancer may some day offer a new treatment option for patients with this disease."

GVAX is currently being studied as a single agent and in combination with docetaxel chemotherapy in two Phase III clinical trials expected to enroll approximately 1,200 patients. Cell Genesys received special protocol assessments from the FDA for each of the Phase III studies and has also received fast-track designation for the product.

GVAX consists of two prostate cancer cell lines that have been modified to secrete granulocyte-macrophage colony stimulating factor, an immune stimulatory hormone.