LINCOLNSHIRE, Illinois (February 27, 2012) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today 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.
"We are very excited by the positive results of this study. This is encouraging news concerning potential GVAX cancer vaccines, especially when combined with other anticancer immunotherapies like IPI, for treatment of 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, prostate cancer and melanoma. We look forward to continuing our collaboration with this well-respected research institute as further studies are conducted." About Pancreatic Cancer
About 95 percent of pancreatic cancer is adenocarcinomas. Patients with pancreatic cancer have one of the poorest five-year survival rates of any form of cancer with median survival around three to six months. Pancreatic cancer is sometimes called a "silent killer" because it does not always cause noticeable symptoms and most symptoms are non-specific and varied. It is for this reason that pancreatic cancer often is not diagnosed until the disease is too advanced for current treatment options to be effective. Therefore, in view of the current poor patient prognosis, the need for novel and improved pancreatic cancer treatments is urgent.