On September 27, 2018 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, reported its update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer (Press release, Oncbiomune, SEP 27, 2018, View Source [SID1234529910]). The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.
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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 study protocol, approximately 120 patients are expected to be enrolled. The patients 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.
"Our excitement is growing as we draw closer to enrollment. We (our Company and the host hospital) have already fielded inquiries from prostate cancer patients interested in participating in the study, which is an encouraging sign about recruitment once the trial is opened," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We think the interest is owed to the strong safety profile and meaningful immunological effect demonstrated in the Phase 1 study of ProscaVax in advanced-stage prostate cancer patients and the simple fact that there are no FDA-approved therapeutic options for the tens of thousands of active surveillance patients that want to be proactive in addressing their cancer. We believe that ProscaVax has a lot to offer these patients and potential future partners as the only vaccine of this type."
In preparation for the trial and other pipeline developments, the Company has taken measures to clean its balance sheet, including recently retiring $900,000 in convertible, floorless debt. Management is currently in negotiations with its lenders and accredited investors to secure additional funding structured under attractive terms, including preferred stock and fixed-rate convertible debentures.
About Prostate Cancer
According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.