SOURCE: OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals, Inc.

May 18, 2016 08:00 ET

Doctors Voice Optimism About Phase 2 Trial of ProscaVax in Mexico for Prostate Cancer

BATON ROUGE, LA--(Marketwired - May 18, 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 share with shareholders the recent comments received by the Company from the doctors overseeing the upcoming Phase 2 trial of ProscaVax in Mexico.

The trial of ProscaVax, OncBioMune's novel cancer vaccine for prostate cancer, will be conducted in Mexico through a Joint Venture with Vitel Laboratorios S.A. de C.V. ("Vitel") and is designed to evaluate the safety and efficacy of ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. Dr. Augusto Bondani Guasti and Dr. Jose Aurelio Athie Rubio, the Principal Investigators for the trial, recently completed their review and approved the protocol for the trial, which is now being submitted to the Mexico Ministry of Health for approval. The doctors recently expressed their excitement for the trial and optimism for ProscaVax to meet their country's need for new prostate cancer therapies to treat the more than 300,000 Mexican men diagnosed with the disease annually.

"Prostate cancer treatments in Mexico are tragically accompanied by severe morbidities and we want to be a part of a solution to this problem," said Dr. Bondani. "Our country's regulatory authorities strongly support innovative projects and products that have a significant impact on the health of the population. Their initiatives to be at the forefront of clinical research and first adopters, such as with the anti-dengue vaccine late in 2015, are quite clear. After evaluating the evidence presented in previous and ongoing studies with ProscaVax, we believe that with similar results in this study, there is a high percentage for approval for marketing authorization in Mexico in record time."

"ProscaVax has proven itself to reduce prostate specific antigen, slow cell proliferation and induce an immunological response, all clear benefits to the prostate patients being treated," commented Dr. Athie. "With the clinical trial to be performed in Mexico, we will be able to better determine the efficacy of the vaccine and are hopeful that ProscaVax will be a great contribution to the treatment of prostate cancer in our country."

In preparation for the commencement of the trial, which is anticipated in the third quarter, OncBioMune management is traveling to Mexico next week to meet with Dr. Bondani andDr. Athie, as well attend appointments to present Proscavax to the Mexican MoH (Secreataria de Salud - SSA) and COFEPRIS (similar to the U.S. Food and Drug Administration) to present the project.

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 are similar to that in the United States, including radiotherapy and other traditional methods that are accompanied by a high rate of morbidities, including impotence and incontinence. Contingent upon clinical results meeting expectations in demonstrating safety and efficacy, OncBioMune and Vitel, through the Joint Venture (OncBioMune Mexico S.A. de C.V.), will pursue a Preliminary Marketing Authorization seeking commercialization for ProscaVax in Mexico, which has the potential to happen in as little as 24 months from the commencement of the Phase 2 study.

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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 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