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Phase II Trial of GVAX for Lung Cancer Patients Expanded
Patients enrolled in the new Phase 2 trial will be randomized to receive GVAX(R) lung cancer vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent which in the doses to be administered has been shown to enhance the immune response. The trial is expected to enroll approximately 75 patients and will be conducted at medical centers across the United States.
"We are pleased to have initiated the first of two expanded Phase 2 trials of GVAX(R) lung cancer vaccine planned for this year, the first trial for which product will be manufactured at our newly-built, 35,000 square-foot GMP manufacturing facility located in Memphis, Tennessee," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Cell Genesys is fortunate to have the financial resources needed to advance multiple clinical stage programs into late-stage development, including the future initiation of a Phase 3 trial of our GVAX(R) lung cancer vaccine product."
At the December 2002 International Conference on Gene Therapy of Cancer, Cell Genesys updated the results of an earlier multicenter Phase 1/2 clinical trial of GVAX(R) lung cancer vaccine in patients with advanced NSCLC. Of 33 treated patients, the majority of whom had failed prior chemotherapy and/or radiation therapy, three patients (9 percent) experienced complete responses (complete disappearance of tumor) with a median duration of response of 17.8 months. Additionally, one of the complete responses was reported to be ongoing at 21.7 months. Of these three patients, two were noted to have BAC and were among only three patients with this diagnosis entered on the trial. The median survival of all 33 treated patients was 11.6 months (measured from the initiation of vaccine manufacturing). These data compare favorably to the reported median survival of 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 vaccine products secreted higher levels of GM-CSF, an immune stimulatory hormone, which all GVAX(R) vaccines are engineered to produce (median survival of 17.1 months for GM-CSF >40 ng./10(6) cells/24 hr. versus median survival of 7.4 months for GM-CSF In the near future, Cell Genesys plans to initiate a second expanded Phase 2 clinical trial of GVAX(R) lung cancer vaccine. This trial will be carried out and partially funded by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the NCI. The study will focus on patients with BAC to further explore the possibility that this type of NSCLC may be particularly responsive to GVAX(R) lung cancer vaccine therapy. Data from this trial could be part of future regulatory filings for product approval. A Phase 3 clinical trial of GVAX(R) lung cancer vaccine in patients with all types of NSCLC is currently targeted to begin at the end of 2003.
In December 2002, 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(R) 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(R) 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 specimens and the distribution of the patient-specific cancer vaccines to treatment centers throughout the United States.
Cell Genesys' GVAX(R) 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(R) 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(R) 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(R) cancer vaccines have demonstrated a favorable side effect profile and have been safely administered to over 500 patients to date.
Clinical Trial Enrollment Information
Patients seeking information about how to participate in the GVAX(R) lung cancer vaccine trial can obtain information by visiting the company's website at www.cellgenesys.com or by calling 650-266-3200.