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OncBioMune and the Clinical Trial Investigators Have Agreed Upon the Protocol for Their Phase 2 Trial of Novel Vaccine for Early Stage Prostate Cancer
OncBioMune and the Clinical Trial Investigators Have Agreed Upon the Protocol for Their Phase 2 Trial of Novel Vaccine for Early Stage Prostate Cancer.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nOncBioMune and the Clinical Trial Investigators Have Agreed Upon the Protocol for Their Phase 2 Trial of Novel Vaccine for Early Stage Prostate Cancer\n\nOncBioMune and the Clinical Trial Investigators Have Agreed Upon the Protocol for Their Phase 2 Trial of Novel Vaccine for Early Stage Prostate Cancer\n\n BATON ROUGE, LA--(Marketwired - December 08, 2016) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (\"OncBioMune\"), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, is pleased to announce that the protocol for the planned Phase 2 trial of ProscaVax, the Company's novel therapeutic cancer vaccine, has been agreed upon by the Principal Investigator and will soon be submitted to the FDA for review.The trial, slated to be hosted at a preeminent cancer research hospital in the Northeast United States and its partners, will evaluate ProscaVax in patients at disease presentation that have not undergone any other therapy. Per the planned protocol, prostate cancer patients will receive ProscaVax during active surveillance and results will be compared to prostate cancer patients not receiving ProscaVax during active surveillance.Early stage prostate cancer patients have very few options, with many opting for a radical prostatectomy, the removal of the prostate gland and some of the surrounding tissue, radiation, brachytherapy or a combination of treatments. Unfortunately, these therapies are known to have significant side effects, including erectile dysfunction and urinary incontinence, amongst other things. There are currently no drugs approved by the U.S. Food and Drug Administration for treating prostate cancer at disease presentation. Given that prostate cancer is often a disease with slow progression, many men decide to track the advance of their disease with their physician without medical intervention, which is termed \"active surveillance.\" In the upcoming Phase 2 trial, the safety and efficacy will be evaluated in patients in the active surveillance category. OncBioMune is unaware of any other pharmaceutical company developing a therapeutic vaccine for this patient population.In a Phase 1 study funded in part by the U.S. Navy Cancer Vaccine Program, ProscaVax was evaluated for safety and efficacy as a novel treatment for PSA (prostate spec...