BATON ROUGE, LA--(Marketwired - December 28, 2016) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) ("OncBioMune" or the "Company"), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, today announces that the Company has been advised that approximately 30 patients have been pre-screened to participate in the Phase 2/3 trial of ProscaVax for prostate cancer in Mexico. The trial is being conducted through a Joint Venture between OncBioMune and the Company's Mexico-based acquisition target, Vitel Laboratorios, S.A. de C.V. ("Vitel").
In the study, ProscaVax, OncBioMune's lead experimental therapeutic cancer vaccine, will be evaluated for safety and efficacy in PSA (prostate specific antigen) recurrent prostate cancer in hormone-naïve and hormone-independent patients. OncBioMune has been further advised that administration of ProscaVax to trial participants is expected to commence shortly after the first of the new year.
The trial is scheduled to enroll 50 patients in the Phase 2 portion. Patients will receive six vaccines of ProscaVax, a combination of the tumor-associated antigen PSA with the biological adjuvants IL-2 and GM-CSF. Under the guidance of regulatory authorities, the Phase 3 portion will enroll 50 additional patients and commence 12 months after the Phase 2 begins. Patients in this portion of the trial will receive six vaccines as well as additional booster regimen of ProscaVax. The trial's endpoints will be reduction in PSA progression and increased immune responses post-vaccination.
Contingent upon clinical results meeting expectations in demonstrating safety and efficacy, OncBioMune intends to seek commercialization of ProscaVax in Mexico through a Preliminary Marketing Authorization, which has the potential to happen in as little as 24 months from the commencement of the Phase 2 study, according to OncBioMune's Mexican advisors.
Prostate cancer is the most frequently diagnosed type of cancer in male patients over 50 years in age in Mexico. Annually, in excess of 300,000 Mexican men are diagnosed with prostate cancer and more than 5,000 deaths result from the disease. Today's treatments for patients with biochemical progression are similar to that in the United States with limited improvement in overall survival.
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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.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
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.