OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (“OncBioMune”), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, is pleased to announce that the protocol for the planned Phase 2 trial of ProscaVax, the Company’s novel therapeutic cancer vaccine, has been agreed upon by the Principal Investigator and will soon be submitted to the FDA for review.
The trial, slated to be hosted at a preeminent cancer research hospital in the Northeast United States and its partners, will evaluate ProscaVax in patients at disease presentation that have not undergone any other therapy. Per the planned protocol, prostate cancer patients will receive ProscaVax during active surveillance and results will be compared to prostate cancer patients not receiving ProscaVax during active surveillance.
Early stage prostate cancer patients have very few options, with many opting for a radical prostatectomy, the removal of the prostate gland and some of the surrounding tissue, radiation, brachytherapy or a combination of treatments. Unfortunately, these therapies are known to have significant side effects, including erectile dysfunction and urinary incontinence, amongst other things. There are currently no drugs approved by the U.S. Food and Drug Administration for treating prostate cancer at disease presentation.
Given that prostate cancer is often a disease with slow progression, many men decide to track the advance of their disease with their physician without medical intervention, which is termed “active surveillance.” In the upcoming Phase 2 trial, the safety and efficacy will be evaluated in patients in the active surveillance category. OncBioMune is unaware of any other pharmaceutical company developing a therapeutic vaccine for this patient population.
In a Phase 1 study funded in part by the U.S. Navy Cancer Vaccine Program, ProscaVax was evaluated for safety and efficacy as a novel treatment for PSA (prostate specific antigen) recurrent prostate cancer in hormone-naïve and hormone-independent patients. The data corroborated earlier research that showed ProscaVax to be extremely safe and deliver a measurable response in reducing PSA and increasing the immune response to PSA.
“To me, it is a tragedy that some 181,000 men diagnosed with prostate cancer this year are left staring at a blank slate of effective low morbidity options. We intend to be a part of the solution for them,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “We already know that ProscaVax has shown clinical responses in late stage patients. I greatly look forward to commencing this new trial to learn even more about the value of ProscaVax by evaluating it in one of the greatest areas of unmet medical need in oncology, early stage prostate cancer patients.”
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax® is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
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This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals’ need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical’s vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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