The two companies struck a deal to enter a joint venture, being coined "OncBioMune Mexico S.A. de C.V.," only six weeks ago for the purpose of developing OncBioMune's vaccine, ProscaVax, in Mexico and throughout Latin America. Per the latest press, the JV will also hold commercialization rights in Europe, China and the rest of the world outside the U.S. as well. ProscaVax is already patented in about 50 countries worldwide.
Vitel has a well-established presence in the Mexican pharmaceutical space and overseas ties and has used their experience to move quickly with signing principal investigators for a Phase 2 trial and set up key meetings with regulatory authorities, similar to the FDA process in the U.S. For the protocol, OncBioMune was able to leverage an ongoing Phase 1 trial in California evaluating ProscaVax in recurrent prostate cancer patients and preparatory work being done for a separate Phase 2 trial planned to be hosted at Beth Israel Deaconess Medical Center and its hospital network on early-stage prostate cancer patients.
The principal investigators for the Phase 2 Mexican trial, which will evaluate ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients, have green lighted the protocol with the final document expected to be submitted to IMSS, the national public health care system in Mexico, in the next few weeks.
The company says that it is receiving tremendous support from Mexican officials with respect to developing ProscaVax, which dovetails with prior statements about potentially hastening the commercialization process if the trial produces positive outcomes. Manuel Cosme Odabachian, CEO of Vitel, has stated that Mexico is aiming to become a global leader in drug development, something that it has typically trailed the world in doing. Prostate cancer, the most frequently diagnosed cancer in men of 50 in the country, is a growing concern in Mexico with its aging population and more than 300,000 new diagnoses each year.
Cosme Odabachian has offered guidance that with parallel commercialization efforts during the trial, ProscaVax could be available in Mexico in as little as 24 months via a Preliminary Marketing Authorization. Simply put, this means that if trial data shows a safe and meaningful therapeutic benefit in prostate cancer patients, regulators could elect to allow the drug to be marketed while the trial is ongoing.
In a phone interview, Andrew Kucharchuk, President and CFO at OncBioMune, focused on the accelerated pathway and said he is extremely encouraged by the interest and support of COFERPRIS, which is akin to the U.S. FDA, and the Mexican Ministry of Health. "Everything is, of course, contingent on the clinical data, but what we've seen so far in human studies of our vaccines has us very optimistic," he said. Kucharchuk explained that he sees this opportunity as a gateway to globalization of a vaccine that has the potential to help "tens of millions" of patients that normally have to face horrible co-morbidities associated with current prostate cancer treatments.
"As professionals, we always must temper expectations and remain sanguine about trial data until it arrives, but this could be a tremendous catalyst for us and we're thrilled with the opportunity," he concluded.
The trial is expected to begin in the third quarter of 2016.
Interested parties can learn more about OncBioMune Pharmaceuticals and their technologies by visiting the company's website (www.oncbiomune.com) and by reading Thursday's press release below.
Mexican Regulatory Authorities Supportive of OncBioMune's Phase 2 of ProscaVax for Prostate Cancer
BATON ROUGE, LA--(June 02, 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 provide shareholders information on the Joint Venture in Mexico with Vitel Laboratorios S.A. de C.V. ("Vitel") for the development of the Company's novel cancer vaccine, ProscaVax, for the treatment of prostate cancer. A Phase 2 trial of ProscaVax is being prepared with expectations for commencement in the third quarter this year in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients.
OncBioMune executives recently traveled to Mexico City for several days of meetings with Vitel, the upcoming Phase 2 trial's Principal Investigators, COFEPRIS (similar to the U.S. Food and Drug Administration) and the Mexican Ministry of Health (Secreataria de Salud - SSA).
Several key developments resulted from the meetings. It was confirmed that submission of the final trial protocol to IMSS, the national public health care system in Mexico, is targeted before June 27, 2016. It was also determined that OncBioMune Mexico S.A. de C.V., the official name of the Joint Venture with Vitel, will include provisions for commercialization of ProscaVax in China, Europe and the rest of the world outside of the United States. Importantly, COFERPRIS expressed extreme interest in the development of ProscaVax, with the agency providing guidance on best practices to "fast track" the registration process in parallel with the clinical study.
"The support that COFERPRIS offered and the interest from the Ministry of Health, was beyond our expectations," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "The meetings crystalized the country's priority to address the growing concern of prostate cancer in Mexico. We feel we are exactly in the right place at the right time. We were thoroughly impressed with the supportive nature of all the parties involved and see a tremendous opportunity to utilize expedited pathways to commercialization should ProscaVax demonstrate efficacy in lowering PSA levels to provide a meaningful clinical benefit to patients in the upcoming trial."
Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune, added, "Things are progressing smoothly towards commencing the trial in Mexico, while we work at requirements for the Phase 2 trial of ProscaVax for early-stage prostate cancer patients in the U.S. Vitel is proving to be an invaluable partner immediately, using its years' of experience to organize the meetings with Mexican agencies, stimulate interest in our Company from venture capital funds and explore potential overseas opportunities, for which it has established relationships."
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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.
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.
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SOURCE OncBioMune Pharmaceuticals, Inc.