BioSante (BPAX) GVAX Pancreas Cancer Vaccine Said to Increase Median Survival Rate

February 27, 2012 7:56 AM EST
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BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX) announced presentation of results from a Phase Ib clinical study that show its GVAX Pancreas cancer vaccine increased the median survival of pancreatic cancer patients with previously treated, locally advanced or metastatic pancreatic adenocarcinoma (PDA), from 3.3 months when treated with ipilimumab (IPI; Yervoy; BMS), to 5.5 months on the combination of IPI plus GVAX Pancreas, an increase of more than 60 percent. The study was not powered for a direct comparison. In addition, the IPI/GVAX Pancreas combination demonstrated an increase in one year survival, from 7 percent to 27 percent. A new multicenter clinical study is planned to begin this year.

A poster titled, “Phase 1b Study of Ipilimumab Alone or in Combination with Allogeneic Pancreatic Tumor Cells Transfected with a GM-CSF Gene in Pancreatic Cancer,” was presented at the 2012 Gastrointestinal Cancers Symposium by Dung T. Le, et al, lead investigator at Johns Hopkins University. The abstract of the poster is in the Journal of Clinical Oncology 30, 2012 (suppl 4; abstr 211). The primary endpoint was to determine the safety profile of IPI alone or in combination with GVAX and the secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. Toxicities were manageable. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that, “Immunotherapy has potential even in advanced PDA.”

The 30 patient Phase Ib study was conducted by researchers at the Sidney Kimmel Cancer Center of Johns Hopkins University School of Medicine and the Bloomberg School of Public Health at Johns Hopkins, in Baltimore, Maryland. BioSante’s Pancreas cancer vaccine is made from allogeneic pancreatic cancer cells genetically modified to produce an immune system stimulator, the cytokine GM-CSF, and irradiated to prevent cell growth. BioSante already has received Orphan Drug designation from the U.S. Food & Drug Administration for its GVAX Pancreas cancer vaccine.

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