Business
Protocol Submitted to FDA for Phase 2 Clinical Trial of ProscaVax as Immunotherapy for Early-Stage Prostate Cancer
Protocol Submitted to FDA for Phase 2 Clinical Trial of ProscaVax as Immunotherapy for Early-Stage Prostate Cancer.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nProtocol Submitted to FDA for Phase 2 Clinical Trial of ProscaVax as Immunotherapy for Early-Stage Prostate Cancer\n\nProtocol Submitted to FDA for Phase 2 Clinical Trial of ProscaVax as Immunotherapy for Early-Stage Prostate Cancer\n\nBATON ROUGE, LA--(Marketwired - June 01, 2017) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (\"OncBioMune\" or the \"Company\"), a clinical stage biopharmaceutical company engaged in the development of targeted cancer therapies and a proprietary vaccine technology, is pleased to announce that the protocol for the Company's upcoming Phase 2 clinical trial of ProscaVax as a novel therapeutic cancer vaccine for early stage prostate cancer has been submitted to the U.S. Food and Drug Administration (FDA) for review. In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients at disease presentation who, in collaboration with their oncologist, chose to forego standard approved therapies in favor of careful monitoring for disease progression, a process known more commonly as \"active surveillance.\"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).There are currently no FDA-approved treatments for patients in active surveillance. Today's approved therapies for early-stage prostate cancer include surgery to remove the prostate and some surrounding tissue (radical prostatectomy), radiation and brachytherapy, all of which are well documented to have unpleasant side effects, including impotence and urinary incontinence.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 will be monitored for disease progression. The follow-up of the patients will be for two years. The investigators are Dr. Rupal Bhatt, Dr. Glenn Bubley and Dr. David Einstein at Beth Israel Deaconess Medical Center of Harvard Medical School. Early clinical research of ProscaVax, including a Phase 1 Clinical Trial that recently completed enrollment in PSA progressing prostate cancer in hormone-naïve and hormo...