>>SAN DIEGO, Calif., Dec. 16 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced encouraging follow-up data from the company's initial Phase I/II multicenter clinical trial of GVAX® lung cancer vaccine, a patient-specific vaccine made directly from patient tumor biopsies. The trial, which was last updated in June 2002, enrolled non small-cell lung cancer patients with advanced, heavily pretreated disease, 73 percent of whom had failed more than two prior chemotherapy regimens. Of the 33 patients who received vaccine, three patients (9 percent) achieved a complete response (complete disappearance of tumor at all disease sites) with a median duration of 17.8 months. One of the complete responses is still ongoing at 21.7 months. Another seven patients (21 percent) had stable disease or minor responses with an overall median duration of 7.7 months. The median survival of all 33 treated patients was 8.6 months (not including the time required to manufacture their vaccines), as compared to the reported 5.7 to 7.0 months for the approved second-line chemotherapy (docetaxel) for such patients or 4.6 months for best supportive care. Moreover, median survival was significantly longer in patients whose vaccines secreted higher levels of GM-CSF, an immune stimulatory hormone, which all GVAX® vaccines are engineered to produce (median survival of 15.7 months for GM-CSF >40 ng./10(6) cells/24 hr. versus median survival of 5.8 months for GM-CSF <40ng./10(6) cells/24 hr., p= .04). These data were presented on Saturday at the International Conference on Gene Therapy of Cancer in San Diego, CA by John Nemunaitis, M.D., director of clinical research of US Oncology.
"We are pleased that GVAX® lung cancer vaccine was able to provide a clinical benefit to some patients, and importantly, without the side effects seen with currently available therapies including chemotherapy and radiation," stated Joseph J. Vallner, Ph.D., president and chief operating officer at Cell Genesys. "We look forward to initiating additional trials in the coming months, with the ultimate goal of being able to provide a new treatment option for these unfortunate patients which produces more robust and durable responses than what is seen with today's currently approved therapies."
In early 2003, Cell Genesys plans to initiate two Phase II clinical trials of GVAX® lung cancer vaccine -- one which is expected to be sponsored and partially funded by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the National Cancer Institute (NCI), and the other which will be sponsored by Cell Genesys. The SWOG-sponsored trial will focus on patients with bronchoalveolar carcinoma (BAC), one of the four principal subtypes of non small-cell lung cancer. BAC was found to be a predictor of increased survival in the advanced patient group involved in the initial Phase I/II clinical trial and was also the subtype in two of the three complete responders mentioned above. The company-sponsored trial will enroll patients with all subtypes of non small-cell lung cancer. In the Cell Genesys-sponsored study, patients will be randomized to receive GVAX® lung cancer vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent which in the doses to be employed has been shown to enhance the immune response. The two trials are expected to treat approximately 100 patients total. Data from these trials could be part of future regulatory filings for product approval. A Phase III clinical trial of GVAX® lung cancer vaccine in patients with all types of non small-cell lung cancer is targeted to begin in late 2003.
In related news, Cell Genesys announced that it had completed construction of its 35,000 square-foot GMP (good manufacturing practices) facility located in Memphis, TN. This facility, which will be used primarily to manufacture GVAX® lung cancer vaccines for future clinical trials and potential subsequent market launch, is currently undergoing validation testing. 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. Memphis is centrally located within the United States and is widely recognized as one of the major shipping hubs in the world. Cell Genesys believes these two factors will help facilitate the receipt of patient tumor cells and the distribution of the patient-specific cancer vaccines to treatment centers throughout the United States.
Cell Genesys' GVAX® cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are used to vaccinate patients to stimulate an immune response against their tumor. GVAX® cancer vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date, and the company is currently evaluating these products in five types of cancer-prostate, lung, 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. With all tumor types and vaccine formats tested, GVAX® cancer vaccines have demonstrated a favorable side effect profile and have been safely administered to over 500 patients to date.<<
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Cheers, Tuck |
