Final Results From Phase 2 Clinical Trial of GVAX Immunotherapy for Prostate Cancer Published in the American Cancer Society's Journal CancerSOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jul 22, 2008 - Cell Genesys, Inc. (Nasdaq:CEGE) announced today the publication of final data from the second of two Phase 2 clinical trials (G-0010) of GVAX immunotherapy for prostate cancer in the online issue of Cancer, a peer-reviewed publication of the American Cancer Society. Results from this multicenter trial indicated an overall median survival of 35.0 months in the subset of patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that currently being evaluated in the ongoing Phase 3 program. These results were consistent with those observed in the first multicenter Phase 2 trial which indicated an overall median survival of 34.9 months in those patients who received a dose comparable to that being evaluated in the Phase 3 program. The survival results from both Phase 2 clinical trials compare favorably to the previously published median survival for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for this patient population. A copy of the article, Phase 1/2 Dose-Escalation Study of a GM-CSF-Secreting, Allogeneic Cellular Immunotherapy for Metastatic Hormone-Refractory Prostate Cancer, can be obtained by visiting http://www3.interscience.wiley.com/journal/120840830/abstract.
"These published Phase 2 data are very encouraging and support our ongoing Phase 3 program for GVAX immunotherapy for prostate cancer which is designed to evaluate the potential survival benefit for this product," stated Robert J. Dow, MBChB, chief medical officer of Cell Genesys. "We are pleased with the progress we continue to make in the program and remain on track to complete enrollment of VITAL-2, the second of the two ongoing Phase 3 trials, in the first half of 2009 and expect to reach the number of events needed to trigger final analysis of VITAL-1, the first of the two Phase 3 trials, in the second half of 2009."
To date Cell Genesys has completed several multicenter trials of GVAX immunotherapy for prostate cancer in patients with different stages of recurrent prostate cancer resulting in consistent findings. As noted above, there have been consistent findings of a potential survival benefit in the two studies in patients with more advanced, hormone-refractory disease. The company has also previously reported consistent findings of a favorable impact on PSA (prostate specific antigen) measurements in two studies of patients with earlier stage, hormone-sensitive disease who had not received hormone therapy and had recurrent disease after surgery and/or radiation therapy. Both of the latter two studies indicated favorable changes in PSA measurements including PSA velocity and/or PSA doubling time. Moreover, in addition to measures of clinical activity, ongoing studies characterizing the immune response in patients who received GVAX immunotherapy for prostate cancer have been recently reported which also show consistent data for these completed trials. More specifically, an ongoing analysis has shown potential associations between the induction of specific antibodies to the GVAX immunotherapy product and observed patient survival in patients with late-stage, hormone-refractory disease and between the induction of such antibodies and improved PSA measurements in patients with earlier stage hormone-naive disease. The company believes that the consistency of both the clinical and immune response data across these clinical trials provide encouraging support for the ongoing Phase 3 program for GVAX immunotherapy for prostate cancer.
About GVAX Immunotherapy for Prostate Cancer
GVAX immunotherapy for prostate cancer is a whole-cell, non patient-specific product designed to present the immune system with a broad spectrum of tumor antigens and stimulate an immune response against the patient's tumor. GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory protein that plays a key role in stimulating the body's immune response, and then irradiated for safety. Cell Genesys, in partnership with Takeda Pharmaceutical Company Limited, is currently evaluating GVAX immunotherapy for prostate cancer in two Phase 3 clinical trials, VITAL-1 and VITAL-2, for the treatment of advanced stage, hormone-refractory prostate cancer. In 2007, the VITAL-1 trial completed enrollment with 626 patients and in January 2008, Cell Genesys announced that the Independent Data Monitoring Committee (IDMC) had completed a pre-planned interim analysis for VITAL-1 in the timeframe originally estimated and recommended that the study continue. The company currently estimates that there will be sufficient events to trigger the final analysis for VITAL-1 in the second half of 2009. Patients are continuing to be enrolled in the VITAL-2 trial at approximately 100 clinical trial sites located in North America and Europe. Cell Genesys is targeting the completion of enrollment for VITAL-2 with approximately 600 patients in the first half of 2009 and expects that there will be sufficient events to trigger the pre-planned interim analysis in the same time frame. GVAX immunotherapy for prostate cancer is currently being manufactured in Cell Genesys' bioreactor manufacturing facility, a facility that is capable of producing the product during commercialization.
About Cell Genesys
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms-GVAX(R) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, which is being developed in partnership with Takeda Pharmaceutical Company Limited, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.
Statements made herein about the company, other than statements of historical fact, including statements about the progress, results, findings and timing of the company's clinical trials and preclinical programs, current and potential corporate partnerships, the nature of product pipelines and anticipated operating results and cash expenditures are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, the ability to raise capital, operating expense levels and the ability to establish and retain corporate partnerships and other risks. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-Q, 10-K, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
Cell Genesys, Inc.
Susan Ferris, 650-266-3200
Posted: July 2008