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OncBioMune Submits Protocol to Initiate Phase 2/3 Trial of ProscaVax for Prostate Cancer

July 13, 2016

BATON ROUGE, LA--(Marketwired - July 13, 2016) - OncBioMune Pharmaceuticals, Inc. (OBMP) ("OncBioMune" or the "Company"), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, today announces that following recent meetings with Mexican health authorities, the protocol for the clinical trial of ProscaVax for prostate cancer has been submitted today to IMSS, the national public health care system in Mexico.

Subsequent to productive dialogue, the protocol is now for a Phase 2/3 clinical trial, rather than a Phase 2 clinical trial as originally disclosed. The trial protocol is similar to the Phase 1 study of ProscaVax at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California, that to date has delivered promising data showing that ProscaVax increases immune responses and reduces PSA progression in PSA recurrent prostate cancer in both hormone-naïve and hormone-independent patients.

The latest trial, which is being conducted through a Joint Venture with Vitel Laboratorios S.A. de C.V. ("Vitel"), will enroll 50 patients in the Phase 2 portion of the study. In this portion of the study, patients will receive six vaccines of ProscaVax, a combination of the tumor-associated antigen PSA with the biological adjuvants IL-2 and GM-CSF. Under the guidance of regulatory authorities, the Phase 3 portion will enroll 50 additional patients and commence 12 months after the Phase 2 begins. Patients in this portion of the trial will receive six vaccines as well as additional booster regimen of ProscaVax.

The trial's endpoints will be reduction in PSA progression and increased immune responses post-vaccination.

OncBioMune has been advised that the trial is still on schedule to commence during this quarter. Clinical sites have been identified and preparatory work is underway to begin patient recruitment, with expectations that the first prostate cancer patients will begin receiving ProscaVax therapy in late August.

"We are very appreciative of the guidance and support from the Mexican health authorities, the trial's Principal Investigators and Vitel in devising our go-to-market strategy for ProscaVax," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We remain confident that ProscaVax will deliver a meaningful clinical benefit to prostate patients in Mexico. If the clinical data supports previous studies, we have a real opportunity to commercialize ProscaVax in Latin America through accelerated Mexican development pathways. We believe this will attract potential partners internationally through Vitel's network and support the clinical development of our novel vaccine in the U.S."

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 for patients with biochemical progression are similar to that in the United States with limited improvement in overall survival.

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