OncBioMune Meets Primary Objective in Trial of ProscaVax Immunotherapy Vaccine for Prostate Cancer
- Category: Vaccines
- Published on Thursday, 14 September 2017 14:44
- Hits: 799
BATON ROUGE, LA, USA I September 14, 2017 I 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.
SOURCE: OncBioMune Pharmaceuticals