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Favorable 2-Year Survival Data Reported From Phase 2 Clinical Trial of GVAX Vaccine for Pancreatic Cancer
The Phase 2 trial was conducted by the Johns Hopkins Kimmel Cancer Center and enrolled 60 patients with resectable pancreatic cancer. Of note, although all patients had resectable disease, 52 of the 60 patients were Stage IIb based on the unfavorable finding that their cancer had spread to regional lymph nodes. The study was designed to evaluate the safety and efficacy of GVAX(R) vaccine for pancreatic cancer which is a non patient-specific vaccine being developed as an "off-the-shelf" pharmaceutical product. All patients underwent extensive surgical resection of their tumors. The vaccine was administered as an intradermal (under the skin) injection before and after standard post-operative adjuvant radiation therapy and continuous infusion 5-flourouracil chemotherapy. Patients received up to five vaccine treatments -- the first prior to adjuvant therapy, the next three following adjuvant therapy at approximately one-month intervals and the fifth as a booster injection six-months later. Patients were monitored for evidence of relapse and survival, as well as the occurrence of adverse events.
"We are certainly encouraged by the initial results of this Phase 2 study with respect to the two-year survival data compared to previously reported results for surgery and adjuvant therapy of resectable pancreatic cancer," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Based on these findings, we plan to discuss with the Food and Drug Administration (FDA) a potential registration strategy for GVAX(R) vaccine for pancreatic cancer."
An earlier Phase 1 trial of GVAX(R) vaccine for pancreatic cancer was conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who received the vaccine following surgical resection of their tumor and standard adjuvant radiation and chemotherapy. As first reported in the Journal of Clinical Oncology in January 2001, three of eight patients who received the therapeutic dose levels of the vaccine had prolonged disease-free survival for a period of at least 7 years. This outcome is considered particularly significant since all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of residual pancreatic tumor following surgery and/or metastatic tumor in regional lymph nodes. In addition, the three patients with prolonged disease-free survival -- but not the five who progressed and died -- had biopsy-proven vaccine-induced antitumor immunity as well as functional evidence of vaccine-induced T cell immunity.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. According to the American Cancer Society, approximately 32,000 Americans will be diagnosed with pancreatic cancer in 2005, nearly all of whom will unfortunately die from their disease. Because symptoms are non-specific, cancer of the pancreas is rarely diagnosed at an early stage leaving surgical removal of the tumor as a treatment option for only approximately 20 to 30 percent of pancreatic cancer patients. The median survival of patients with operable cancer of the pancreas is approximately 12 to 18 months.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple types of cancer in addition to pancreatic cancer, including prostate cancer and leukemia. GVAX(R) vaccines are whole-cell vaccines that are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been genetically modified to secrete GM-CSF, an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines and are being developed as non patient-specific "off-the-shelf" pharmaceutical products. GVAX(R) cancer vaccines have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.
Source: Cell Genesys, Inc.