The Orphan Drug designation of GVAX Acute Myeloid Leukemia Vaccine for the treatment of acute myeloid leukemia is BioSante ™s second GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October. On March 15, BioSante reported receiving orphan drug designation for its GVAX Pancreas Vaccine to treat pancreatic cancer.

It is our intention to find ways to continue the development of our GVAX cancer vaccines using the benefits conferred by gaining Orphan Drug designation. Further, these orphan drug designations alert the FDA that we are dedicated to bringing better cancer therapy to patients in need, Simes continued.

Currently, clinical trials of GVAX cancer vaccines against many different cancer types are being conducted, including leukemia, pancreatic cancer and breast cancer. It is estimated that approximately 12,810 individuals in the U.S. will be diagnosed with AML in 2010 and approximately 9,000 deaths will occur. AML is quite resistant to currently available treatments, and approximately 76% of these patients will die of their disease. The 3-year overall survival rate currently is about 20%.

Source BioSante Pharmaceuticals, Inc.