Mexican Regulatory Authorities Supportive of OncBioMune's Phase 2 of ProscaVax for Prostate Cancer

OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced information on the Joint Venture in Mexico with Vitel Laboratorios S.A. de C.V. 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.
As quoted in the press release:

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.

OncBioMune Pharmaceuticals CEO, Dr. Jonathan Head, stated:

The support that COFERPRIS offered and the interest from the Ministry of Health, was beyond our expectations. 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.

OncBioMune Pharmaceuticals President and CFO, Andrew Kucharchuk, stated:

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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