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. About BioSante Pharmaceuticals, Inc. BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (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 (FDA). BioSante’s other products include Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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. Additional information is available online at: www.biosantepharma.com. Forward-Looking Statements To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future clinical studies and the potential of BioSante’s GVAX cancer vaccines, and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “expects,” “anticipates,” “plans,” “may,” “potential,” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the success of clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of BioSante's licensees or sublicensees and BioSante’s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante’s product development programs and its need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante’s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.