SOURCE: OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals, Inc.

May 11, 2016 09:10 ET

OncBioMune Provides Update on Phase 2 Clinical Trials of ProscaVax for Prostate Cancer

BATON ROUGE, LA--(Marketwired - May 11, 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 provides shareholders with an update on the clinical advancement of ProscaVax, the Company's novel cancer vaccine in development for prostate cancer.

In the United States, a Phase 1a/1b trial of ProscaVax is ongoing at the Veterans' Administration Medical Center and the University of California San Diego Medical School, both in La Jolla, California. 16 of 20 patients have been enrolled in the 1a portion of the study with clinical data analyzed on 12 patients so far. Data to date shows ProscaVax to have a meaningful impact in reducing the rise in PSA (prostate specific antigen) levels in 60% (6 out of 10) of patients receiving six vaccinations and an increased immune response in 89% (8 out of 9) patients at 31 weeks after administration of the vaccine. No ProscaVax-related adverse events have occurred during the trial, matching the results from prior studies of ProscaVax and other vaccines built upon the vaccine platform. As previously disclosed, the data is compelling enough that OncBioMune has elected to forego the Phase 1b component and advance ProscaVax into two, separate Phase 2 studies.

The Company is preparing to initiate one of the Phase 2 trials at one of the world's leading university hospital networks located in the Northeast U.S. The trial will enroll patients at presentation of prostate cancer, a time where there are currently no therapeutic options other than surgery or radiation therapies, both of which have well documented morbidity issues. To the best of the Company's knowledge, ProscaVax will be the only cancer vaccine in the world in mid-stage clinical research evaluating safety and efficacy in prostate cancer patients in the "active surveillance" category.

The trial protocol was submitted to the Principal Investigator of the trial, Dr. Glenn J. Bubley, Director of Genitourinary Oncology at Beth Israel Deaconess Medical Center, last week for review. Dr. Bubley has informed us that he has almost completed his review and the protocol and once completed it will be submitted to the Institutional Review Board overseeing the trial for review and comments.

"Addressing prostate cancer at disease presentation is a key in developing a front-line defense to treat the disease, but no company has successfully accomplished this," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We have published testimonials from early recipients of ProscaVax attributing their health and longevity to ProscaVax, testimonials that we hope can be reinforced with larger studies. Dr. Bubley has expressed his excitement for the trial, which in itself is an extreme vote of confidence for ProscaVax, and we greatly look forward to commencing the trial."

In Mexico, OncBioMune has forged a Joint Venture, named "OncBioMune Mexico," with Vitel Laboratorios S.A. de C.V. for additional clinical research of the vaccine platform technology, beginning with ProscaVax for prostate cancer. A Phase 2 trial is planned to evaluate ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients, similar to the Phase 1a/1b trial in the U.S. The protocol has been submitted and reviewed by the Principal Investigators overseeing the trial, Dr. Bondani and Dr. Athie, and now will be submitted to the Mexico Ministry of Health for approval.

OncBioMune executives are traveling to Mexico during the third week of May to meet with the Dr. Bondani, Dr. Athie, Secretaría de Salud and Ministry of Health officials to finalize details of the trial.

"Through laboratory data, in-house clinical trials and FDA trials, we have data supporting the effect of ProscaVax," added Dr. Head. "The trials in the U.S. and Mexico are reflective of our commitment to address prostate cancer at any stage. With roughly one million men being diagnosed with the disease in North, Latin and South America each year, there is a tremendous opportunity in front of us that we will not relent in pursuing for the good of humanity and our shareholders."

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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