BATON ROUGE, LA–(Uptick Newswire – 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 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 study 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.
“We are very excited to move forward on a trial for patients on Active Surveillance for prostate cancer. Immune therapies have shown promise across many fields in oncology and we hope that ProscaVax™ can show activity in patients with low risk prostate cancer,” said Dr. Rupal Bhatt.
Sign up for OncBioMune email alerts at: www.oncbiomune.com/email-alerts/.
About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a revenue-stage biopharmaceutical company engaged 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.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals’ need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical’s vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
OncBioMune Pharmaceuticals, Inc.
President and Chief Financial Officer
Source: Uptick Newswire