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news.OncBioMune Pharmaceuticals has signed a contract to form a Joint Venture (JV) with Vitel Laboratorios to develop and commercializie OncBioMune's portfolio of innovative cancer therapies in Mexico and Latin America.
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The documentation is being prepared to create the JV as a legal entity named OncBioMune Mexico S.A. de C.V. ("OncBioMune Mexico"). It has been agreed that Dr. Jonathan Head, Chief Executive Officer and Chairman of OncBioMune, will serve as Chief Executive Officer and President of OncBioMune Mexico. Manuel Cosme Odabachian, Chief Executive Officer of Vitel, will serve as Secretary of OncBioMune Mexico.
During the process of formally creating the JV, OncBioMune and Vitel are working collaboratively to design a Phase 2 clinical trial of ProscaVax, OncBioMune’s novel vaccine for the treatment of prostate cancer.
The protocol is being developed and the host hospital and doctors that will be overseeing the trial have already been identified and agreed to be involved in the study.
The trial will evaluate ProscaVax, a combination of the tumor-associated antigen PSA with the biological adjuvants IL-2 and GM-CSF, in treating both PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients and, patients in active surveillance population.
The first category is a similar patient population to that being evaluated in an ongoing Phase 1 clinical trial of ProscaVax at University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California. Data recently released by the Company showed an increased immune response in 89% (8 out of 9) patients at 31 weeks post vaccine and reduction in PSA progression in 60% (6 out of 10) patients after receiving six vaccinations.
"Many months of negotiations and planning with Vitel are coming together very quickly into a mid-stage trial of ProscaVax in Mexico, a country that, much like the U.S., is in great need of an effective therapy to treat prostate cancer," commented Dr. Head.
"Vitel is a tremendous partner and is using its experience and vast network to spearhead our initiative to expedite development."
"Mexico is looking to better position itself as a leader in drug development. While still careful to keep safety the top priority, there is a favorable regulatory framework for development of drugs for serious diseases like prostate cancer," added Manuel Cosme Odabachian.
"The scientific evidence and Phase 1 data on ProscaVax are very compelling and if the vaccine can improve outcomes and lower PSA in a larger patient sample, we believe there is a strong case for accelerated commercialization in Mexico, perhaps about two years from the start of the trial."