Latest Clinical Data from OncBioMune Supports Safety and Therapeutic Profile of ProscaVax for Prostate Cancer for Upcoming Phase 2 Clinical Trials
- Category: Vaccines
- Published on Friday, 27 January 2017 19:47
- Hits: 1713
BATON ROUGE, LA, USA I January 26, 2017 I OncBioMune Pharmaceuticals, Inc. (OBMP) ("OncBioMune" or the "Company"), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, today provides the latest clinical data of ProscaVax, the Company's novel therapeutic prostate cancer vaccine.
In the ongoing Phase 1 clinical trial, ProscaVax is being evaluated for safety and efficacy in prostate specific antigen (PSA) recurrent prostate cancer in hormone-naïve and hormone-independent patients. Per protocol, 20 patients are expected to be enrolled in the 1a portion of the study, with therapy consisting of six ProscaVax induction vaccinations at a single dose. To date, 16 prostate cancer patients have enrolled in the trial.
The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under an IND from the U.S. Food and Drug Administration with funding from the U.S. Navy Cancer Vaccine Program.
Additional preliminary data from the trial shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:
- 15 of 20 patients* in the Phase 1a portion of the trial have received at least one vaccine injection and 14 patients have received all 6 vaccines.
- None of the 15 patients who have had at least one vaccine have had a DLAE.
- None of the 14 patients who have received all 6 vaccines in the Phase 1a have had a DLAE.
- 9 of the 14 patients that have received 6 vaccines have had increased PSA doubling time, suggesting ProscaVax is slowing tumor growth.
- 11 of the 13 patients** that have received 6 vaccines have had increased immune responses to PSA as determined with a Lymphocyte Blastogenesis Assay by 31 weeks post-vaccine.
- 3 of the 14 patients that have received all 6 vaccines have experienced disease progression (one radiological, two PSA)
Data from this trial combined with previous in-house studies have established a strong safety profile for ProscaVax, while providing evidence of a therapeutic benefit that warrants larger clinical trials. OncBioMune is preparing to enter a Phase 2/3 trial in Mexico through a Joint Venture with its acquisition target and Mexican partner Vitel Laboratorios S.A. de C.V. Inclusion criteria for the Phase 2/3 trial will be similar to the ongoing Phase 1 trial. A second Phase 2 trial is planned in the United States at a prominent Northeast university cancer center evaluating ProscaVax at disease presentation in early-stage prostate cancer patients in the "active surveillance" population.
"We're very excited by the updated data that once again supports our thesis that ProscaVax can provide a meaningful benefit to prostate cancer patients without the horrible side effects well known to accompany today's approved therapies," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We greatly look forward to our upcoming Phase 2 studies where we will be adding six ProscaVax booster injections, which we believe has the potential to further increase efficacy for both early and late-stage prostate cancer patients."
* one enrolled patient failed a screening test and was forced to withdraw from study
** one patient was not evaluated with LBA due to a blood sample error by the hospital
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
SOURCE: OncBioMune Pharmaceuticals