The study reported at ASCO employed a six-month treatment regimen in which patients received an initial "priming" dose of GVAX® prostate cancer vaccine followed by 12 biweekly "booster” doses using either a high dose or threefold lower dose regimen. The two dose groups were comparable with respect to disease stage, duration and prior treatment for their prostate cancer as well as other demographic criteria. The vaccine, which is a non patient-specific, “off-the-shelf” product was administered by an intradermal injection into the skin of the arms and legs in an outpatient clinic setting. Patients were observed for evidence of vaccine efficacy and safety using standard clinical and radiologic tests. No other cancer therapies aside from the GVAX® vaccine were administered during either the six-month treatment or post treatment follow-up period.
“These encouraging data have prompted Cell Genesys to plan a Phase III trial of GVAX® prostate cancer vaccine which we expect to initiate in the first half of 2003. Prior to initiating this trial, we will have the necessary manufacturing and quality control infrastructure in place to ensure the highest quality of product will be available for our Phase III trials and potential subsequent market launch,” stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. “Given the data presented today, we believe that GVAX® prostate cancer vaccine may provide an attractive alternative to chemotherapy which is the only treatment option currently available to patients with metastatic hormone refractory prostate cancer.”
Based on the compelling dose response data in the Phase II trial of GVAX® prostate cancer vaccine, Cell Genesys is currently conducting Phase I/II clinical trials to evaluate a high potency GVAX® prostate cancer vaccine that secretes five to tenfold greater levels of the immune stimulatory hormone which is an active ingredient of all GVAX® products. These ongoing trials are also testing alternate schedules of administration for the high potency product and will be completed prior to its advancement into Phase III trials during the first half of 2003.
In preparation for the company’s Phase III GVAX® prostate cancer vaccine clinical trial, Cell Genesys is constructing a 41,000 square-foot manufacturing facility in nearby Hayward, CA, which will be used for the manufacturing of multiple GVAX® cancer vaccine products for large scale clinical trials and potential market launch. The new GMP (Good Manufacturing Practices) facility, which is expected to be on-line in late 2002, is in addition to the company’s two other GMP manufacturing facilities—a facility in San Diego, CA for manufacturing the company’s viral based products such as oncolytic virus therapies, and a facility under construction in Memphis, TN for manufacturing the company’s patient-specific GVAX® lung cancer vaccine, which is expected to enter Phase III trials in late 2002.
Cell Genesys’ GVAX® cancer vaccines, which are designed to stimulate an immune response against the patient’s tumor, are comprised of tumor cells that have been irradiated and genetically modified to secrete GM-CSF, an immune hormone which plays a key role in stimulating the body’s immune response to vaccines. GVAX® cancer vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date and are currently being evaluated in five types of cancer—lung, prostate, pancreatic, leukemia and myeloma. Currently, Cell Genesys is evaluating non patient-specific, off-the-shelf GVAX® vaccines for prostate cancer and pancreatic cancer and patient-specific, individualized vaccines for lung cancer, leukemia and myeloma.
GVAX® prostate cancer vaccine is one of two types of products targeting prostate cancer currently in clinical development at Cell Genesys. In addition to GVAX® prostate cancer vaccine which is an immune-based therapy administered as a single agent, Cell Genesys is also developing oncolytic virus therapies for prostate cancer which are genetically modified adenoviruses engineered to selectively destroy prostate cancer cells and which will be administered in combination with radiation or chemotherapy. During 2002, it is projected that in the U.S. alone, approximately 189,000 new cases of prostate cancer will be diagnosed, approximately one million men are living with prostate cancer, and about 30,200 men will die of this disease. Prostate cancer is the second leading cause of cancer death in men, exceeded only by lung cancer.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms—GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in lung cancer, prostate cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys’ majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.
Clinical Trial Enrollment Information
Patients seeking information about how to participate in a GVAX® prostate cancer vaccine trial can obtain information by visiting the company’s website at www.cellgenesys.com or by calling (650) 425-4542.
Statements made herein, other than statements of historical fact, including statements about the company’s and its subsidiaries’ progress, results of clinical trials including trials evaluating GVAX® cancer vaccines, marketability and success of potential products, projected product development timelines and nature and growth of product pipelines 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 continuation of research collaborations, the success of research and development programs, results achieved in future preclinical studies and clinical trials, the regulatory approval process, competitive technologies and products, the scope and validity of patents, corporate partnerships and additional financings. For information about these and other risks which may affect Cell Genesys, please see the company’s Annual Report on Form 10-K dated April 1, 2002 as well as Cell Genesys’ reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.