OncBioMune has begun the process to initiate clinical studies of OvcaVax for ovarian cancer.
BATON ROUGE, La., Oct. 17, 2017 (GLOBE NEWSWIRE) -- OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of a proprietary cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, is pleased to inform shareholders that the company has begun the process to initiate clinical studies of OvcaVax for ovarian cancer. Built upon the same platform as ProscaVax, the Company’s novel therapeutic vaccine for prostate cancer, OvcaVax is therapeutic ovarian cancer vaccine consisting of a combination of cancer antigen 125 (CA-125), interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
In the coming weeks, OncBioMune management will be scheduling CA-125 manufacturing under cGMP standards and conducting meetings with contract research organization Theradex Oncology to discuss trial protocol, site location and trial budget. Based upon initial dialogue, the intentions are for a small study enrolling approximately 20 ovarian cancer patients at varying stages of disease to receive OvcaVax in an adjuvant setting following a surgical procedure. Endpoints will include safety, progression-free survival and overall survival.
OncBioMune also intends to pursue select U.S. Food and Drug Administration pathways, such as Orphan Drug designation or Fast Track designation, that can expedite development of OvcaVax and provide extra intellectual property protection should OvcaVax successfully complete clinical trials and be approved for commercialization in the future.
“During our in-house trials, we previously treated four ovarian cancer patients with advanced disease with no signs of toxicity. That data combined with hundreds of other patients receiving vaccinations from the platform technology has us confident in the safety profile of OvcaVax,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Recently, we collected very compelling data on ProscaVax eliciting an increased immune response and slowing tumor progression in prostate cancer and believe the same is possible in late-stage ovarian cancer, where women are left with very few therapeutic options. I firmly believe that immunotherapeutic cancer vaccines will one day be a part of standard of care for hard-to-treat disease. Our vaccine technology is on the leading edge of this paradigm shift, so I am eager to initiate these studies of OvcaVax concurrent with the mid-stage studies of ProscaVax.”
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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.
Forward-Looking Statements
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.
Contact:
OncBioMune Pharmaceuticals, Inc.
Andrew Kucharchuk
President and Chief Financial Officer
akucharchuk@oncbiomune.com
