Business
Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement
Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nPhase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement\n\nPhase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement\n\nBATON ROUGE, LA--(Marketwired - July 13, 2017) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (\"OncBioMune\" or the \"Company\"), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, is pleased to announce that the protocol for the planned Phase 2 trial of ProscaVax for treatment-naïve prostate cancer patients is awaiting approval from the Institutional Review Board (IRB) at the host hospital, a preeminent North-eastern U.S. cancer research network. The protocol was previously submitted to the U.S. Food and Drug Administration and received no comments within the 30-day comment period.\"The IRB review is the final approval necessary for us to begin the first mid-stage trial of a therapeutic prostate cancer vaccine for newly diagnosed patients that we are aware of,\" commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. \"We are approaching a watershed moment for our company and the hundreds of thousands of newly-diagnosed men suffering from the slow progressing disease, We are eager to get the trial underway.\"ProscaVax is an immunotherapeutic cancer vaccine consisting of a combination of the tumor-associated antigen PSA (prostate specific antigen) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).Per the protocol, ProscaVax will be evaluated for safety, tolerability and efficacy as a novel therapy for patients at disease presentation who, in collaboration with their oncologist, chose to forego standard approved therapies, such as a radical prostatectomy, radiation or brachytherapy, in favor of careful monitoring for disease progression, a process known more commonly as \"active surveillance.\" Presently, there are no FDA-approved treatments for prostate cancer patients in active surveillance.As submitted, the Phase 2 clinical protocol will randomly enroll 120 early-stage prostate cancer patients with 40 patients on standard active surveillance and 80 patients receiving ProscaVax. The patients' PSAs and yearly biopsies wil...