- ProscaVax is OncBioMune’s lead immunotherapy platform candidate
- Ph I trials led to PSA reductions in 3/4 of patients
OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company") announced on 6/20/2018 that all requisite approvals have been granted to commence a Phase 2 clinical trial of ProscaVax for early-stage prostate cancer to be hosted at Beth Israel Deaconess Medical Center a teaching hospital of Harvard University Medical School in Boston, MA.
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 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.
“We are making the final preparations to initiate enrollment, including planned site visits,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Underscored by the compelling data derived from the successfully completed Phase 1a clinical trial and our other research, we are eager to proceed with this study. Our goal is simple: to provide a safe, nontoxic. front-line therapy for prostate cancer patients that are otherwise left with either no therapy or with much more invasive options that typically have very unpleasant side effects, such as impotence or urinary incontinence. I’d like to express my gratitude for all the shareholders that have supported us throughout the process to advance our company to this next stage of ProscaVax development. I believe there is a bright future ahead of us.”
Concurrent with the Phase 2 trial of patients in active surveillance, the Company is undergoing the approval process to initiate a Phase 2 trial of ProscaVax in hormone-naïve recurrent prostate cancer patients with increasing PSA at theUrology Clinics of North Texas. More updates on the status of this study are expected soon.
In the company's Ph I trials 12 patients with confirmed prostate cancer received 6 vaccinations with ProscaVax. Two-thirds of the prostate cancer patients’ PSAs decreased after vaccination.