BioSante vaccine increases median survival of resected pancreatic cancer patients

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase II clinical study that show BioSante's Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year.

In the study, titled, "A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation," published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. The median disease-free survival of patients was 17.3 months (95% CI, 14.6-22.8) with median survival of 24.8 months (95% CI, 21.2-31.6). The administration of immunotherapy was well tolerated. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that "an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer."

The 60 patient Phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante's Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. BioSante already has received Orphan Drug designation from the U.S. Food & Drug Administration for the Pancreas Cancer Vaccine

"We are very excited by the positive results of this study. This is encouraging news concerning potential treatment for a disease that can be so devastating for so many patients," said Stephen M. Simes, BioSante's president & CEO. "Besides pancreatic cancer, Johns Hopkins researchers also are investigating the use of BioSante's cancer vaccines for the treatment of several different forms of cancer, including leukemia, breast cancer and multiple myeloma. We look forward to continuing our collaboration with this well-respected research institute as further studies are conducted."