Cell Genesys, Inc. (Nasdaq: CEGE) announced final, updated results from its second multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer (HRPC).
Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company’s ongoing Phase 3 program indicates that the median survival is 35.0 months.
Four patients have withdrawn consent to further follow-up and thus were censored in the analysis. The company previously reported final median survival results from its first multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer in 34 patients with metastatic HRPC that showed an overall median survival of 26.2 months.
The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company’s ongoing Phase 3 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 2 trial of GVAX immunotherapy for prostate cancer. The final median survival of 35.0 months also compares favorably to a predicted median survival of 22.0 months for these 22 patients based on a validated, published nomogram using seven prognostic variables,” stated Rob Dow, M.D., chief medical officer of Cell Genesys. “We continue to hope that GVAX immunotherapy for prostate cancer may some day offer a new treatment option for patients with this disease.”
GVAX immunotherapy for prostate cancer is currently being studied as a single agent and in combination with docetaxel chemotherapy in two Phase 3 clinical trials expected to enroll approximately 1,200 patients with metastatic HRPC. Cell Genesys received Special Protocol Assessments (SPA) from the Food and Drug Administration (FDA) for each of the Phase 3 studies and has also received Fast Track designation for the product. GVAX immunotherapy for prostate cancer is comprised of two prostate cancer cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient-specific, “off-the-shelf” pharmaceutical product.