>>ORLANDO, Fla., May 21 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today reported interim data from a multicenter Phase I/II trial of a new form of the company's patient-specific GVAX® lung cancer vaccine. The trial is expected to evaluate approximately 40 patients with advanced non small-cell lung cancer, most of whom have failed prior treatment with radiation and/or chemotherapy. The preliminary findings indicate that this form of the patient-specific vaccine, which is prepared from a mixture of individual patient tumor cells and a non patient-specific GVAX® product manufactured at Cell Genesys, could be efficiently manufactured in 87 percent of the patients entered on the trial. Vaccine treatment was well tolerated and demonstrated evidence of antitumor immunity, and evaluations for tumor response are ongoing. While the company expects to continue to evaluate this new form of vaccine in future clinical trials, Phase III trials of GVAX® lung cancer vaccine, which are targeted to begin in late 2002, will be conducted with a previously developed form of the product for which positive clinical data were reported during 2001. The interim data on the new product format were presented at the American Society of Clinical Oncology (ASCO) Meeting in Orlando, FL by John Nemunaitis, M.D. of U.S. Oncology.
"We continue to be pleased with the progress we are making in our GVAX® clinical trial programs across multiple fronts," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Given the encouraging clinical data Cell Genesys has previously reported for GVAX® lung cancer vaccine, we plan to initiate a Phase III trial late this year and has begun discussions with the FDA regarding the design of this trial."
In late 2001, Cell Genesys reported data from its first multicenter Phase I/II trial of GVAX® lung cancer vaccine. The trial evaluated a form of GVAX® vaccine produced directly from patients' own tumor cells. The trial included 36 evaluable patients with non small-cell lung cancer, 26 of whom were advanced stage patients who failed prior therapies and 10 of whom were early stage patients at high risk of recurrence following surgery. Of the 26 advanced stage patients, three patients (12 percent) achieved a complete response (complete disappearance of tumor at all disease sites) with a median duration of at least 11 months. Seven other patients (27 percent) in this group were reported to have stable disease with a median duration of at least six months. In the early stage group, eight of the 10 patients were reported to be disease free after surgery with a median duration of at least 12 months.
In preparation for the company's Phase III GVAX® lung cancer vaccine clinical trial expected to begin in late 2002, Cell Genesys is constructing a 35,000 square-foot manufacturing facility in Memphis, TN, which will be used for the manufacturing of the company's patient-specific GVAX® lung cancer vaccines for Phase III clinical trials and potential market launch. In addition, the company has developed a semi-automated closed system that it expects to use to manufacture its patient-specific GVAX® lung cancer vaccines, which has been designed to enable the safe and sterile manufacturing of each patient's vaccine in approximately four hours. The new GMP (Good Manufacturing Practices) facility in Memphis, which is expected to be on-line in late 2002, is in addition to the company's other two GMP manufacturing facilities -- a facility under construction in nearby Hayward, CA for manufacturing the company's non patient-specific GVAX® cancer vaccines such as GVAX® prostate cancer vaccine and GVAX® pancreatic cancer vaccine and a facility in San Diego, CA for manufacturing the company's viral based products such as oncolytic virus therapies.
In related news, interim clinical data from a Phase I trial of GVAX® vaccine for ovarian cancer were also reported at the ASCO Meeting by Glenn Dranoff, M.D. of Dana-Farber Partners Cancer Care. The trial, which was an investigator-sponsored study, is utilizing a patient-specific form of GVAX® cancer vaccine which requires the genetic modification of the patients' cells to generate the vaccine. The data revealed that the vaccine was safe and well tolerated and induced a tumor-specific immune response in all of the treated patients.<<
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