BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase I dose escalation clinical study that show its GVAX Prostate cancer vaccine in treating metastatic castration-resistant prostate cancer patients (mCRPC) in combination with ipilimumab (Ipi; Yervoy; BMS), resulted in 53 percent of patients achieving at least stable disease, with two patients showing clear regression of metastases. In addition, 23 percent of patients in the higher dose cohorts had confirmed partial PSA (prostate specific antigen) responses of greater than 50 percent from baseline. The study, titled, “Combined Immunotherapy with Granulocyte-Macrophage Colony-Stimulating Factor-Transduced Allogeneic Prostate Cancer Cells and Ipilimumab in Patients with Metastatic Castration-Resistant Prostate Cancer: a Phase 1 Dose Escalation Trial” was published in current issue of The Lancet Oncology (February 2012). The study combined fixed doses of GVAX Prostate in combination with escalating 0.1, 0.3, 1.0, 3.0 and 5.0 mg/kg doses of Ipi. The study enrolled 12 patients in three dose escalation cohorts and 16 patients in an expansion Ipi 3.0 mg/kg cohort. The reported duration of disease stabilization ranged from 3-27 months, and the median duration of PSA response was 12 months, (range 2-21 months). There were no serious adverse events in the lower dose Ipi cohorts and administration of immunotherapy was well tolerated and safe. The investigators concluded that, “Further research on the combined treatment of patients with mCRPC with vaccination and Ipilimumab is warranted.” The 28 patient Phase I study was conducted by researchers at the VU University Medical Centre in Amsterdam, Netherlands. BioSante’s Prostate cancer vaccine is made from allogeneic prostate cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. A Phase II GVAX Prostate clinical trial is anticipated to begin in 2012 at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. “We are very excited by the positive results of this prostate cancer study notably combined with recently reported excellent results in pancreatic cancer. This is encouraging news concerning the potential for 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 & chief executive officer.
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 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 USA, Inc., 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 the timing of a Phase II GVAX Prostate clinical trial and the potential for GVAX cancer vaccines, and other statements identified by words such as “anticipates,” “will,” “continue,” “could,” “believe,” “intends,” “expects,” “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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other 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 BioSante’s 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.