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news.OncBioMune Pharmaceuticals has signed a Memorandum of Understanding (MOU) with Vitel Laboratorios for the purpose of establishing a Joint Venture (JV), to be named OncBioMune Mexico, to develop and commercialize OncBioMune’s portfolio of innovative cancer therapies in Mexico and Latin America.
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The initial focus of the JV will be immediately advancing ProscaVax, OncBioMune’s novel prostate cancer vaccine combining a tumor-associated antigen with biological adjuvants, into a Phase 2A/2B clinical trial in Mexico.
The planned 100-patient clinical trial will be structured as a two-stage study of ProscaVax (PSA/IL-2/GM-CSF) for the treatment of PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. The trial is expected to last 36 months.
Should preliminary data from the study show efficacy, a Preliminary Marketing Authorization will be pursued to commercialize ProscaVax in Mexico, which has the potential to happen in as little as 24 months from the commencement of the Phase 2A/2B study.
In the United States, ProscaVax is currently in a Phase 1 clinical trial for relapsed prostate cancer patients and scheduled for a Phase 2 clinical trial for prostate cancer patients at disease presentation at a preeminent cancer institution in the Northeast United States later in 2016. In addition to the Phase 2A/2B trial in Mexico under the direction of OncBioMune Mexico, these trials will continue as planned under the direction of OncBioMune Pharmaceuticals.
"This partnership with Vitel is an outstanding opportunity for us to widen our pipeline, contain clinical trial expenses and expedite the development of ProscaVax with the goal of commercialization into the extremely large markets of Mexico and Latin America," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune.
"Vitel’s principals have deep knowledge of the clinical process, regulatory affairs and distribution in Mexico and Latin America, which brings a complete solution after the trials are successful. We are very confident in the safety and efficacy of ProscaVax in lowering PSA levels in prostate cancer patients and this is the perfect marriage of skill sets to develop ProscaVax and grow shareholder value."
"We are extremely impressed with the data on ProscaVax and OncBioMune’s leadership. An aging population and the dearth of safe and effective treatments for prostate cancer has our markets crying out for a blockbuster drug for the millions of patients in need in Mexico and through Latin America. We hope that this partnership will be able to answer that call with ProscaVax," said Manuel Cosme Odabachian, Chief Executive Officer at Vitel.
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 high morbidities. The lack of new, innovative therapies and high diagnosis rate has made prostate cancer an area of great unmet medical need in Mexico.