SOURCE: OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals, Inc.

May 04, 2016 08:30 ET

OncBioMune Submits Protocol to Principal Investigators for Two Phase 2 Clinical Trials of ProscaVax for Prostate Cancer

BATON ROUGE, LA--(Marketwired - May 04, 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, is pleased to announce that the protocol has been submitted to the Principal Investigator for the planned Phase 2 clinical trial to be hosted by a major university in the Northeast United States and its network of cancer centers. Glenn J. Bubley, MD, Director of Genitourinary Oncology at Beth Israel Deaconess Medical Center who has agreed to serve as the trial's Principal Investigator, is currently reviewing the documentation for submission to the U.S. Food and Drug Administration ("FDA").

The trial is designed to evaluate ProscaVax, OncBioMune's novel cancer vaccine, in prostate cancer patients at disease presentation. Currently, patients at this stage are placed in the "active surveillance" category, meaning that they are simply monitored and tested regularly for disease progression. Aside from surgery or radiation therapy, which both pose serious risks of impotence and/or incontinence, there are no FDA-approved treatments early-stage prostate cancer, the time when it is most appropriate to address the disease. Throughout in house clinical trials and an ongoing Phase 1 trial in recurrent prostate cancer patients, ProscaVax has been shown to be safe, without a single dose limiting adverse event, while showing signs of efficacy with respect to increasing immune response and reducing PSA (prostate specific antigen) progression.

Elsewhere, the physicians overseeing the planned Phase 2 clinical trial of ProscaVax for prostate cancer in Mexico are reviewing the protocol prior to submission to the Ministry of Health. The trial, being conducted through a Joint Venture with Vitel Laboratorios S.A. de C.V., will evaluate ProscaVax in treating PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients.

"Details are being finalized for submission of both Phase 2 protocols to the respective regulatory agencies in the U.S. and Mexico," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We have a very clear goal: to show that ProscaVax is a safe and effective option for any stage of prostate cancer, from the earliest at disease presentation to the latest, where patients have relapsed. We are optimistic that initiating these two, separate trials will demonstrate that ProscaVax is one of the leading immunotherapies in development today."

Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.

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 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.

Forward-Looking Statements

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.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    OncBioMune Pharmaceuticals, Inc.
    Andrew Kucharchuk
    President and Chief Financial Officer
    akucharchuk@oncbiomune.com