Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement
BATON ROUGE, LA--(Marketwired - July 13, 2017) - OncBioMune Pharmaceuticals, Inc. (OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, is pleased to announce that the protocol for the planned Phase 2 trial of ProscaVax for treatment-naïve prostate cancer patients is awaiting approval from the Institutional Review Board (IRB) at the host hospital, a preeminent North-eastern U.S. cancer research network. The protocol was previously submitted to the U.S. Food and Drug Administration and received no comments within the 30-day comment period.
"The IRB review is the final approval necessary for us to begin the first mid-stage trial of a therapeutic prostate cancer vaccine for newly diagnosed patients that we are aware of," commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. "We are approaching a watershed moment for our company and the hundreds of thousands of newly-diagnosed men suffering from the slow progressing disease, We are eager to get the trial underway."
ProscaVax is an immunotherapeutic cancer vaccine consisting of a combination of the tumor-associated antigen PSA (prostate specific antigen) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Per the protocol, ProscaVax will be evaluated for safety, tolerability and efficacy as a novel therapy for patients at disease presentation who, in collaboration with their oncologist, chose to forego standard approved therapies, such as a radical prostatectomy, radiation or brachytherapy, in favor of careful monitoring for disease progression, a process known more commonly as "active surveillance." Presently, there are no FDA-approved treatments for prostate cancer patients in active surveillance.
As submitted, the Phase 2 clinical protocol will randomly enroll 120 early-stage prostate cancer patients with 40 patients on standard active surveillance and 80 patients receiving ProscaVax. The patients' PSAs and yearly biopsies will be monitored for disease progression. The follow-up of the patients will be for two years. The investigators are Dr. Rupal Bhatt, Dr. Glenn Bubley and Dr. David Einstein at Beth Israel Deaconess Medical Center of Harvard Medical School. Early clinical research of ProscaVax, including a Phase 1 study in PSA progressing prostate cancer in hormone-naïve and hormone-independent patients, has shown ProscaVax to be well tolerated with a strong safety profile. Data from late-stage patients further shows signs of efficacy with respect to an increased immune response and slowing tumor progression.
"We are very excited to move forward on a trial for patients on Active Surveillance for prostate cancer. Immune therapies have shown promise across many fields in oncology and we hope that ProscaVax™ can show activity in patients with low risk prostate cancer," said Dr. Rupal Bhatt.
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