LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. today announced that development of its GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been reinitiated. Manufacturing of new GVAX Prostate is in process, regulatory steps to lift the GVAX Prostate clinical hold prior to trial initiation are being taken, and prostate cancer patients are expected to be treated in a Phase II human clinical trial beginning in the fourth quarter of 2010 at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.
Reinitiation of the GVAX Prostate Vaccine is a cooperative program among BioSante, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and the Prostate Cancer Foundation. BioSante is funding the manufacturing of the GVAX Prostate vaccine, the Phase II clinical trial will be conducted by Johns Hopkins, and the trial will be supported in part by the Prostate Cancer Foundation. Important start-up funding for this study was provided by the OneInSix Foundation.
“We have worked with GVAX Prostate Cancer Vaccine for several years and believe there is great potential to develop a treatment regimen that will be a significant benefit to men who suffer with prostate cancer,” said Charles G. Drake MD, PhD, Associate Professor - Oncology, Immunology and Urology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. “We are happy to be working with BioSante, the Prostate Cancer Foundation and the OneInSix Foundation on this important prostate cancer project.”
“We are pleased to be working with Johns Hopkins as well as the Foundations on such an important project,” said Stephen M. Simes, BioSante’s president and chief executive officer. “Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that our GVAX Prostate can be a valuable addition to prostate cancer patient care.”
Unlike the recently approved Provenge for the treatment of prostate cancer, which requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX Prostate is administered via intradermal injections on an outpatient basis. To date, over 1,000 patients have been treated in clinical trials with GVAX cancer vaccines for various types of cancer. Although Phase III trials in prostate cancer were discontinued in 2008, development of GVAX Prostate has been reinitiated in view of the great need among men with prostate cancer and the lessons learned using GVAX in previous clinical trials.
In addition to GVAX Prostate, BioSante has several other GVAX cancer vaccines which are in Phase II clinical development including vaccines for leukemia, breast cancer and pancreatic cancer. Also, BioSante has applied for and received FDA Orphan Drug designation for GVAX AML for the treatment of acute myeloid leukemia and GVAX Pancreas for the treatment of pancreatic cancer.
About the Prostate Cancer Foundation (PCF)
The Prostate Cancer Foundation (PCF) is the world’s largest philanthropic source of support for accelerating the world’s most promising research for discovering better treatments and cures for prostate cancer. Founded in 1993, the PCF has raised nearly $400 million and provided funding to more than 1,500 researchers at nearly 200 institutions worldwide. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds for transformational cancer research. Its efforts have helped produce a 20-fold increase in government funding for prostate cancer. More information about the PCF can be found at www.pcf.org.
About the OneInSix Foundation
The OneInSix Foundation is so-named because one in six American men will be diagnosed with prostate cancer. This charitable organization was founded by the late Mr. Bruce Hunsicker, an attorney from Akron, Ohio who dedicated his time and effort to raising funds for prostate cancer research and awareness.
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) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development is a portfolio of cancer vaccines (GVAX), two of which have been granted orphan drug designation, currently in several Phase II clinical trials, at minimal cost to BioSante. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ: TEVA - News) and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as “may,” “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” the negative of these words or other words of similar meaning 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 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; BioSante’s need for and ability to obtain additional financing; the effect of general business and economic conditions; and risks arising from BioSante’s merger with Cell Genesys. 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 . The information set forth in this news release speaks only as of the date hereof, and BioSante undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
Contact:
Alan Zachary, McKinney/Chicago; (312) 944-6784 ext. 316; azachary@mckinneychicago.com;
