BioSante Pharmaceuticals, Inc. (BPAX) Monday said results from a Phase Ib clinical study of its GVAX Pancreas cancer vaccine showed an over 60 percent increase in the median survival of patients with previously treated, locally advanced or metastatic pancreatic adenocarcinoma or PDA. The results are derived from a comparison with Ipilimumab or IPI.
BioSante said the study was not powered for a direct comparison. 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. BioSante has received Orphan Drug designation from the U.S. Food & Drug Administration for the GVAX Pancreas cancer vaccine.
The median survival when treated with Bristol-Myers Squibb Company Co (BMY)'s Yervoy (ipilimumab) was 3.3 months. For the combination of IPI plus GVAX Pancreas, the median survival was 5.5 months.
In addition, the IPI/GVAX Pancreas combination demonstrated an increase in one year survival, from 7 percent to 27 percent.
The company said the results demonstrated that toxicities were manageable. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlated with disease-free survival.
The investigators concluded that, "Immunotherapy has potential even in advanced PDA."
Biosante is planning to begin a new multicenter clinical study this year.
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.
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.
Stephen 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."
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.
BioSante's products include LibiGel (transdermal testosterone gel) for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder or HSDD, which is in Phase III clinical development.
BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration.
BioSante's first FDA-approved product is Elestrin (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante's licensee.
BPAX is currently trading at $0.86, up $0.15 or 21.11%, on a volume of 13.2 million shares, on the Nasdaq. Over the past year, the stock traded in a range of $0.38 - $4.02, with three-month average volume of 8.3 million shares.
by RTT Staff Writer
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