Final Patient Completes Treatment in OncBioMune Clinical Trial of ProscaVax for Prostate Cancer
BATON ROUGE, LA–(Marketwired – August 24, 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 20th and final patient in the Phase 1A portion of a Phase 1 trial of ProscaVax for prostate cancer completed treatment per protocol. In the study, ProscaVax, the Company’s novel immunotherapeutic cancer vaccine consisting of a combination of tumor-associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), is being evaluated for safety, tolerability and efficacy in PSA-progressing prostate cancer in hormone-naïve and hormone-independent patients.
The interventional, open label trial is being hosted at the University of California San Diego Moores Cancer Center and the Veterans Hospital in La Jolla, California under an investigational new drug (IND) application from the U.S. Food and Drug Administration with funding from the U.S. Navy Cancer Vaccine Program. The original study design for the trial included a second stage, which OncBioMune has previously disclosed that it will forego due to favorable interim safety results from the 1A stage to initiate two separate Phase 2 clinical trials evaluating ProscaVax in both early-stage prostate cancer at Beth Israel Deaconess Medical Center and also in late-stage prostate cancer patients in a prominent hospital network in Mexico.
“To date, ProscaVax has been very well tolerated with no serious adverse events related to the vaccine in the trial. To that end, we are optimistic that the treatment of the final patient will continue on trend, so the study will meet its primary endpoint of no dose limiting adverse events 30 days subsequent to the last injection,” commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. “We look forward to the final data on the primary endpoint of safety early in September and later analysis of the complete data set to look for further validation of signs of efficacy based upon increased immune responses and slowing of disease progression that was found in interim analysis.”
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a revenue-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, including a proprietary vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. OncBioMune is also involved in drug development and commercialization internationally through our wholly-owned subsidiary, OncBioMune México, S.A. De C.V. Our lead pipeline product, ProscaVax™, is scheduled to commence two, separate mid-stage clinical trials in 2017: a Phase 2 for early-stage prostate cancer at a major Northwest U.S. university cancer research hospital and a Phase 2/3 study in Mexico for late-stage prostate cancer patients. OncBioMune has a portfolio of targeted and licensed therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.