Cell Genesys Completes Construction of Manufacturing Facility for Phase III Clinical Trials
Thursday November 7, 7:02 am ET
FOSTER CITY, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced that the company has completed construction of the portion of its Hayward, CA manufacturing facility necessary to support the company's Phase III clinical trial of GVAX® prostate cancer vaccine, expected to begin by mid-2003. Encouraging results including survival data from the company's Phase II trial of GVAX® prostate cancer vaccine in hormone refractory prostate cancer patients prompted the company to prepare for the planned Phase III trial. The Hayward manufacturing facility is currently undergoing validation testing. Cell production -- a key portion of the vaccine manufacturing process -- has begun at the site in preparation for Phase III manufacturing.
"Our success in establishing the manufacturing capabilities for GVAX® prostate cancer vaccine and other similar products to follow addresses the FDA's requirement to manufacture product for market launch in the same facility used to manufacture Phase III product," stated Michael W. Ramsay, senior vice president, manufacturing operations at Cell Genesys. "Moreover, six of the nine members of our executive team at Cell Genesys have been through successful product approvals, and we intend to use this experience and that of our manufacturing team to carefully steer Cell Genesys' product candidates through the product development and commercialization process."
Cell Genesys has established a leadership position in manufacturing capabilities for both cell and viral-based cancer therapeutic products. Cell Genesys' three GMP (Good Manufacturing Practices) manufacturing facilities are designed to support clinical production requirements for Phase III studies and potential product launch. The 41,000 square-foot Hayward facility will be used to manufacture the company's non patient-specific GVAX® cancer vaccines such as GVAX® prostate cancer vaccine and GVAX® pancreatic cancer vaccine. This GMP manufacturing facility is expected to be fully validated and on-line by early 2003. Non patient-specific GVAX® cancer vaccines will be manufactured in the Hayward facility, while patient-specific GVAX® lung cancer vaccines will be manufactured at the company's 35,000 square-foot Memphis manufacturing facility, which is also expected to be on-line by early 2003. Viral-based products such as the company's oncolytic virus therapies and gene therapies are being manufactured in the company's 48,000 square-foot San Diego manufacturing facility.
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 (granulocyte- macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response to vaccines. Clinical trials of GVAX® cancer vaccines are under way for multiple types of cancer including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma.
In September 2002, the company updated long-term survival data from its initial Phase II trial of GVAX® prostate cancer vaccine involving 34 patients with hormone refractory prostate cancer metastatic to the bone. Five of 10 patients (50 percent) receiving the higher of two dose levels of the vaccine were reported to be alive 2.5 years after treatment (median survival = 31 months). Of the 24 patients receiving the lower dose of the vaccine, seven of 22 patients (32 percent) were reported to be alive 2.5 years after treatment (median survival = 22 months), and two were lost to follow-up. These results compare favorably to the reported median survival of seven to 11 months for hormone refractory prostate cancer patients with bone metastases who are treated with chemotherapy, the current standard of care for this patient group. Based on the compelling dose response data in this Phase II trial, Cell Genesys is currently conducting Phase I/II clinical trials to evaluate GVAX® prostate cancer vaccine that secretes higher levels of GM- CSF. This is the version of GVAX® prostate cancer vaccine that Cell Genesys expects to evaluate in its Phase III clinical trial expected to begin by mid- 2003.
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 prostate cancer, lung 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.
Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress of clinical trials, expectations regarding manufacturing facilities, timelines and future plans for clinical programs, marketability and success of potential products and nature of product pipelines, licensing agreements, partnering expectations and revenue expectations 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 research and development programs, the success and results of clinical trials, the regulatory approval process, competitive technologies and products, patents 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.
CONTACT: Jennifer Cook Williams, Associate Director, Corporate Communications of Cell Genesys, Inc., +1-650-425-4542.
--------------------------------------------------------------------------------
Source: Cell Genesys, Inc. |
