Opthea Recruits 176th Patient and On-Track to Report Primary Data Analysis Early 2020
OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, today announces the signing of a work order with leading Contract Research Organization, Theradex Oncology (“Theradex”), detailing the scope to be provided by Theradex for a clinical trial titled, “A Phase 2, Randomized Study of ProscaVax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naïve Patients with Clinically Localized Prostate Cancer Versus and Active Surveillance Strategy.” The trial, expected to enroll 120 patients, is being hosted at Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.
“We’re extremely pleased to have Theradex once again working with us on the development of ProscaVax,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Theradex is highly sought after for their experience and expertise in advancing promising cancer therapies and we are fortunate to have them on board to provide oversight and the necessary documentation to move this important trial efficiently forward.”
OncBioMune has received all necessary approvals from the host hospital, associated committees and the U.S. Food and Drug Administration to begin the Phase 2 trial. All requisite information has been submitted to clinicaltrials.gov, with the expectations that the summary of the trial will soon be available for public viewing.
ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Per the Phase 2 study protocol, patients to be enrolled will be in what is termed “active surveillance,” a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.