OncBioMune Meets Primary Objective In Trial Of Proscavax Immunotherapy Vaccine For Prostate Cancer
Published: Sep 14, 2017
BATON ROUGE, La., Sept. 14, 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 report that the Company’s Phase 1a trial of ProscaVax has met its primary objective of no Dose Limiting Adverse Events (DLAEs) 30 days post-final vaccination in any of the 20 patients receiving six vaccinations per protocol. Moreover, in the trial, which is evaluating ProscaVax for safety and tolerability in recurrent prostate cancer patients with increasing prostate specific antigen (PSA), no serious adverse events related to ProscaVax were reported, further validating ProscaVax’s safety profile.
ProscaVax is OncBioMune's novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). The study enrolled 20 biochemically progressing prostate cancer patients, four of which dropped out due to disease progression (3 with increasing PSA, 1 radiological).
The study further evaluated secondary objectives that could suggest efficacy for ProscaVax having a meaningful benefit in treating late-stage prostate cancer. At a median follow-up of 31 months post-final vaccination, 9 of the 14 evaluable patients (64.3%) who received all six vaccinations had increased PSA doubling time, suggesting ProscaVax was slowing tumor growth. 12 of 15 patients (80.0%) completing the protocol had an increased immune response to PSA as determined with a Lymphocyte Blastogenesis Assay.
“These results are exactly in line with what we were expecting in the Phase 1a study, no toxicity and indications of a therapeutic benefit with ProscaVax therapy,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “The data is supportive of both of our upcoming Phase 2 trials of ProscaVax, one in a similar patient population in Mexico and a second, first-of-its-kind trial of a therapeutic vaccine at disease presentation at Harvard and its hospital network. We greatly look forward to mid-stage trials to further examine the safety and benefit of ProscaVax for so many patients in need of treatments without the well-documented, dreadful side effects of today’s therapies.”
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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.
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