BATON ROUGE, LA—(June 27, 2017) – OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, today announces that the Company has been advised that the Mexico health authority, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), is officially authorizing commencement of the study. OncBioMune is working with the host hospital, principal investigators and others involved in the trial to begin enrollment immediately.
“This is what we’ve been waiting for and we greatly look forward to enrolling the first patient in the trial in our bid to fill an unmet medical need in Mexico,” commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. “Unfortunately, the more than 300,000 Mexican men diagnosed with prostate cancer each year have limited therapeutic options and none without a high degree of risk of morbidities. We hope to change that with ProscaVax, which we believe will reproduce the strong safety and efficacy profiles that we saw in the Phase 1 study at the University of California San Diego.”
In the study, OncBioMune’s immunotherapeutic vaccine, ProscaVax, will be evaluated in prostate specific antigen (PSA) recurrent prostate cancer in hormone-naïve and hormone-independent patients. The trial is scheduled to enroll 50 patients in the Phase 2 portion. Patients will receive six vaccines of ProscaVax, a combination of the tumor-associated antigen PSA with the biological adjuvants IL-2 and GM-CSF. The Phase 3 portion will enroll 50 additional patients and is expected to commence 12 months after the Phase 2 begins. Patients in this portion of the trial will receive six vaccines as well as an additional booster regimen of ProscaVax. The trial’s endpoints will be reduction in PSA progression and increased immune responses post-vaccination.
Contingent upon clinical results meeting expectations in demonstrating safety and efficacy, OncBioMune intends to seek commercialization of ProscaVax in Mexico through a Preliminary Marketing Authorization. OncBioMune has been advised that this 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 revenue-stage biopharmaceutical company engaged the development of novel cancer immunotherapy products, including a proprietary vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. OncBioMune is also involved in drug development and commercialization internationally through our wholly-owned subsidiary, OncBioMune México, S.A. De C.V. Our lead pipeline product, ProscaVax™, is scheduled to commence two, separate mid-stage clinical trials in 2017: a Phase 2 for early-stage prostate cancer at a major Northwest U.S. university cancer research hospital and a Phase 2/3 study in Mexico for late-stage prostate cancer patients. OncBioMune has a portfolio of targeted and licensed therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
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:
OncBioMune Pharmaceuticals, Inc.
Andrew Kucharchuk
President and Chief Financial Officer
[email protected]