Doctors Voice Optimism About Phase 2 Trial of ProscaVax in Mexico for Prostate Cancer

OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced the recent comments received by the Company from the doctors overseeing the upcoming Phase 2 trial of ProscaVax in Mexico.
As quoted in the press release:

The trial of ProscaVax, OncBioMune’s novel cancer vaccine for prostate cancer, will be conducted in Mexico through a Joint Venture with Vitel Laboratorios S.A. de C.V. (“Vitel”) and is designed to evaluate the safety and efficacy of ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. Dr. Augusto Bondani Guasti and Dr. Jose Aurelio Athie Rubio, the Principal Investigators for the trial, recently completed their review and approved the protocol for the trial, which is now being submitted to the Mexico Ministry of Health for approval. The doctors recently expressed their excitement for the trial and optimism for ProscaVax to meet their country’s need for new prostate cancer therapies to treat the more than 300,000 Mexican men diagnosed with the disease annually.
In preparation for the commencement of the trial, which is anticipated in the third quarter, OncBioMune management is traveling to Mexico next week to meet with Dr. Bondani andDr. Athie, as well attend appointments to present Proscavax to the Mexican MoH (Secreataria de Salud – SSA) and COFEPRIS (similar to the U.S. Food and Drug Administration) to present the project.
Prostate cancer is the most frequently diagnosed type of cancer in male patients over 50 years in age in Mexico. Annually, in excess of 300,000 Mexican men are diagnosed with prostate cancer and more than 5,000 deaths result from the disease. Today’s treatments are similar to that in the United States, including radiotherapy and other traditional methods that are accompanied by a high rate of morbidities, including impotence and incontinence. Contingent upon clinical results meeting expectations in demonstrating safety and efficacy, OncBioMune and Vitel, through the Joint Venture (OncBioMune Mexico S.A. de C.V.), will pursue a Preliminary Marketing Authorization seeking commercialization for ProscaVax in Mexico, which has the potential to happen in as little as 24 months from the commencement of the Phase 2 study.

Dr. Augusto Bondani Guasti stated:

Prostate cancer treatments in Mexico are tragically accompanied by severe morbidities and we want to be a part of a solution to this problem. Our country’s regulatory authorities strongly support innovative projects and products that have a significant impact on the health of the population. Their initiatives to be at the forefront of clinical research and first adopters, such as with the anti-dengue vaccine late in 2015, are quite clear. After evaluating the evidence presented in previous and ongoing studies with ProscaVax, we believe that with similar results in this study, there is a high percentage for approval for marketing authorization in Mexico in record time.

Dr. Jose Aurelio Athie Rubio stated:

ProscaVax has proven itself to reduce prostate specific antigen, slow cell proliferation and induce an immunological response, all clear benefits to the prostate patients being treated. With the clinical trial to be performed in Mexico, we will be able to better determine the efficacy of the vaccine and are hopeful that ProscaVax will be a great contribution to the treatment of prostate cancer in our country.

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