SOURCE: OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals, Inc.

June 14, 2016 10:02 ET

OncBioMune Provides Corporate Update; ASCO Reinforces Market Opportunity for New Prostate Cancer Vaccine as Phase 2 Trial Approaches

BATON ROUGE, LA--(Marketwired - June 14, 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 corporate and clinical developments.

Mexican Trials of ProscaVax for Prostate Cancer

OncBioMune, with its joint venture partner Vitel Laboratorios S.A. de C.V. ("Vitel"), is near commencement of a Phase 2 clinical trial of the Company's novel cancer vaccine, ProscaVax, for the treatment of PSA (prostate specific antigen) recurrent prostate cancer in hormone-naïve and hormone-independent patients. Following successful meetings two weeks ago in Mexico with drug development authorities, parties involved in the upcoming Phase 2 trial and Vitel, OncBioMune executives have been invited next week to attend additional meetings with other scientists and venture capital funds interested in learning more about opportunities involving the trial and OncBioMune's vaccine technology platform.

OncBioMune has also been advised that preparations for the Phase 2 trial are progressing smoothly and that patient screening and trial enrollment remains on target for the third quarter. We remain very encouraged by the support of the Mexican health authorities and guidance from Vitel that there is a clear path for expedited commercialization of ProscaVax if the trial can deliver results showing a meaningful therapeutic benefit of ProscaVax in reduction of PSA.

"The past few months have been very exciting for us as it seems that the investor and the scientific communities are really taking notice of how promising our vaccine technology is," commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. "We had a tremendous turnout for our presentation at the LD Micro Invitational last week in Los Angeles, subsequently participating in dozens of meetings about our Company and ProscaVax. Vitel has informed us that several entities in their network are interested in face-to-face meetings, which we interpret as a very optimistic sign given the history of successes for Vitel principals."

ProscaVax in the U.S.

A Phase 1 trial of ProscaVax in PSA recurrent prostate cancer patients is ongoing. Sixteen patients in the Phase 1a portion of the trial have been enrolled, with promising data collected to date. As previously disclosed, OncBioMune is foregoing the Phase 1b portion of the trial, instead moving directly forward with Phase 2 trials in both Mexico and the United States.

The Phase 1a trial has clearly validated previous studies in hundreds of patients showing that the vaccine platform is without toxicity. As of the last data analysis, none of the 14 patients receiving at least one ProscaVax vaccine experienced a dose limiting adverse event (DLAE). None of the 12 patients who received six ProscaVax vaccines (per protocol guidelines for completing therapy) had a DLAE. 9 of 12 patients (75%) who received six ProscaVax vaccines had increased immune responses to PSA as determined by a lymphocyte blastogenesis assay (LBA).

The latest data set from the trial is presently being analyzed. OncBioMune anticipates releasing the latest data in the coming weeks.

A Phase 2 trial of ProscaVax is being planned for early-stage prostate cancer patients, with ProscaVax to be evaluated as a front-line treatment for prostate cancer patients in the "active surveillance" category. To the best of the Company's knowledge, the Phase 2 trial of ProscaVax will be the only trial of a vaccine in prostate cancer at this early stage a disease, a time when only surgery or radiation, both of which are known to have frequent and severe co-morbidities, are proven therapies. The protocol has been submitted to the intended host hospital, a prominent network of cancer hospitals in the Northeast United States. Dr. Glenn Bubley, a renowned expert in genitourinary, has agreed to serve as the trial's Principal Investigator. OncBioMune expects documentation from the hospital necessary to move the trial towards commencement in the coming weeks.

A ProscaVax recipient from a previous study has agreed to participate in a video testimonial of the vaccine. He first received ProscaVax in 2007and is still receiving ProscaVax boosters every year. After nine years of treatment, his cancer remains clinically stable, a fact that he attributes to ProscaVax. The video is scheduled to be recorded this month with release anticipated during July.

ASCO

Dr. Jonathan Head, Chief Executive Officer at OncBioMune, attended the American Society Of Clinical Oncology (ASCO) Annual Meeting 2016 held in Chicago, Illinois on June 3-7, 2016. OncBioMune's abstract was published for ASCO 2016 and during his time there he meet with experts in the field of prostate cancer.

"I came away from ASCO with further confirmation that scientists and physicians are actively looking for better therapies with fewer co-morbidities to treat prostate cancer," commented Dr. Head. "The glaring fact that the scientific community realizes that prostate cancer patients are still being over-treated causing impotence and/or incontinence, or under-treated and simply waiting for disease progression, reinforces the need for less toxic therapies for patients at diagnosis. Obviously, neither present approach is practical or beneficial to the patient. The ASCO meeting reinforced our position more than ever that there is a tremendous market opportunity for ProscaVax, which we believe will potentially open expedited pathways to market to meet an area of great unmet medical need."

Intellectual Property

OncBioMune has received five new patents so far in 2016 for its technologies, which now include 16 patents and patents pending covering approximately 50 countries worldwide.

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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