OncBioMune Submits Protocol to Principal Investigators for Two Phase 2 Clinical Trials of ProscaVax for Prostate Cancer
OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced that the protocol has been submitted to the Principal Investigator for the planned Phase 2 clinical trial to be hosted by a major university in the Northeast United States and its network of cancer centers.
OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced that the protocol has been submitted to the Principal Investigator for the planned Phase 2 clinical trial to be hosted by a major university in the Northeast United States and its network of cancer centers. Glenn J. Bubley, MD, Director of Genitourinary Oncology at Beth Israel Deaconess Medical Center who has agreed to serve as the trial’s Principal Investigator, is currently reviewing the documentation for submission to the U.S. Food and Drug Administration.
As quoted in the press release:
The trial is designed to evaluate ProscaVax, OncBioMune’s novel cancer vaccine, in prostate cancer patients at disease presentation. Currently, patients at this stage are placed in the “active surveillance” category, meaning that they are simply monitored and tested regularly for disease progression. Aside from surgery or radiation therapy, which both pose serious risks of impotence and/or incontinence, there are no FDA-approved treatments early-stage prostate cancer, the time when it is most appropriate to address the disease. Throughout in house clinical trials and an ongoing Phase 1 trial in recurrent prostate cancer patients, ProscaVax has been shown to be safe, without a single dose limiting adverse event, while showing signs of efficacy with respect to increasing immune response and reducing PSA (prostate specific antigen) progression.
Elsewhere, the physicians overseeing the planned Phase 2 clinical trial of ProscaVax for prostate cancer in Mexico are reviewing the protocol prior to submission to the Ministry of Health. The trial, being conducted through a Joint Venture with Vitel Laboratorios S.A. de C.V., will evaluate ProscaVax in treating PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients.
OncBioMune CEO, Dr. Jonathan Head, stated:
Details are being finalized for submission of both Phase 2 protocols to the respective regulatory agencies in the U.S. and Mexico. We have a very clear goal: to show that ProscaVax is a safe and effective option for any stage of prostate cancer, from the earliest at disease presentation to the latest, where patients have relapsed. We are optimistic that initiating these two, separate trials will demonstrate that ProscaVax is one of the leading immunotherapies in development today.