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.”
About Pancreatic CancerAbout 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 lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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 BioSante’s plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or 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 difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. 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. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.