SOURCE: OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals, Inc.

July 13, 2016 06:30 ET

OncBioMune Submits Protocol to Initiate Phase 2/3 Trial of ProscaVax for Prostate Cancer

BATON ROUGE, LA--(Marketwired - July 13, 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 following recent meetings with Mexican health authorities, the protocol for the clinical trial of ProscaVax for prostate cancer has been submitted today to IMSS, the national public health care system in Mexico.

Subsequent to productive dialogue, the protocol is now for a Phase 2/3 clinical trial, rather than a Phase 2 clinical trial as originally disclosed. The trial protocol is similar to the Phase 1 study of ProscaVax at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California, that to date has delivered promising data showing that ProscaVax increases immune responses and reduces PSA progression in PSA recurrent prostate cancer in both hormone-naïve and hormone-independent patients.

The latest trial, which is being conducted through a Joint Venture with Vitel Laboratorios S.A. de C.V. ("Vitel"), will enroll 50 patients in the Phase 2 portion of the study. In this portion of the study, 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.

OncBioMune has been advised that the trial is still on schedule to commence during this quarter. Clinical sites have been identified and preparatory work is underway to begin patient recruitment, with expectations that the first prostate cancer patients will begin receiving ProscaVax therapy in late August.

"We are very appreciative of the guidance and support from the Mexican health authorities, the trial's Principal Investigators and Vitel in devising our go-to-market strategy for ProscaVax," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We remain confident that ProscaVax will deliver a meaningful clinical benefit to prostate patients in Mexico. If the clinical data supports previous studies, we have a real opportunity to commercialize ProscaVax in Latin America through accelerated Mexican development pathways. We believe this will attract potential partners internationally through Vitel's network and support the clinical development of our novel vaccine in the U.S."

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 early 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 Pharmaceutical's 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