CHICAGO--(BUSINESS WIRE)-- BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the FDA’s clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by FDA. Manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway.
BioSante funded the manufacturing of GVAX Prostate, 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.
“The Prostate Cancer Foundation funded the early work at Johns Hopkins University that resulted in the development of the GVAX Prostate Cancer Vaccine. We are pleased to continue support of Dr. Charles Drake and his innovative clinical and laboratory investigations of GVAX at Hopkins,” said Howard R. Soule, PhD, executive vice president and chief science officer of the Prostate Cancer Foundation. “We are delighted that the OneInSix Foundation has joined in support of this important prostate cancer program. Under BioSante leadership we are hopeful that GVAX Prostate will be established as a new treatment for men with advanced prostate cancer.”
“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. “A joint effort among the various parties involved has resulted in the FDA lifting the GVAX Prostate clinical hold which is a positive step for development of a new prostate cancer vaccine and the men who may benefit. Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that 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 will be administered via intradermal injections on an outpatient basis. To date, over 1,000 patients have been treated in clinical trials with BioSante 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 the vaccine in previous clinical trials.
In addition to GVAX Prostate, BioSante has several other 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 four FDA Orphan Drug designations for cancer vaccines to treat acute myeloid leukemia, chronic myeloid leukemia, pancreatic cancer and melanoma.
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 $450 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) 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 (SPA). 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 Azur Pharma, BioSante’s licensee. 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 BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
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, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words 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 report 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.
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