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Cell Genesys Reports Additional Data From Phase 2 Clinical Trial of GVAX Immunotherapy for Pancreatic Cancer

ru, M.D., assistant professor of medical oncology at Johns Hopkins Kimmel Cancer Center, and colleagues, at the 2007 American Society of Clinical Oncology (ASCO) annual meeting being held in Chicago, IL.

"We continue to be encouraged by the survival data analysis, as well as the immunologic data reported today in this Phase 2 study of GVAX immunotherapy for pancreatic cancer in patients with operable disease," said Kristen Hege, M.D., vice president of Clinical Research at Cell Genesys. "We look forward to the results of ongoing studies conducted by Johns Hopkins which include a study of booster administrations to patients in the completed Phase 2 trial as well as a second 60-patient Phase 2 trial of GVAX immunotherapy with booster administrations following pancreatic cancer surgery and adjuvant radiation and chemotherapy. In addition, we are also looking forward to the results of a third ongoing Phase 2 trial in patients with metastatic pancreatic cancer also being conducted by Johns Hopkins, which is evaluating GVAX immunotherapy in combination with Erbitux(R), an antibody to the EGF receptor.

"The Phase 2 study reported today was designed to evaluate the safety and efficacy of GVAX immunotherapy for pancreatic cancer which is being developed as a non patient-specific "off-the-shelf" pharmaceutical product. All patients underwent extensive surgical resection of their tumors. The immunotherapy was administered as an intradermal (under the skin) injection before and after standard post-operative adjuvant radiation therapy and 5- flourouracil chemotherapy. Patients received up to five doses -- the first prior to adjuvant chemoradiotherapy, 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 and induction of immune response.

An earlier Phase 1 trial o
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