Protocol Submitted to FDA for Phase 2 Clinical Trial of ProscaVax as Immunotherapy for Early-Stage Prostate Cancer
BATON 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 hormone-independent patients, has shown ProscaVax to be well tolerated with a strong safety profile. Data from late-stage patients further shows signs of efficacy with respect to an increased immune response and slowing tumor progression.
“This is a major step in our goal to provide a safe and effective option to more than 160,000 men that are diagnosed with prostate cancer each year in the U.S.,” said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “There is never an easy point to initiate therapy in prostate cancer, but the decision to intervene at disease presentation can be especially troublesome due to the undesirable side effects that can result from today’s standards of care. Our clinical research to date suggests that ProscaVax will be able to deliver a clinically meaningful therapeutic effect for these patients without any significant toxicities. This would be a significant advancement in patient care and improvement in the quality of life of prostate cancer patients.”
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
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OncBioMune Pharmaceuticals, Inc.
President and Chief Financial Officer