OncBioMune Initiates Phase 2 Clinical Trial of Novel Vaccine as Front-Line Treatment for Prostate Cancer
BATON ROUGE, La., Sept. 27, 2018 (GLOBE NEWSWIRE) -- 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 provides a status update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer. 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.
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.
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, based on their proprietary vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. Our lead pipeline product, ProscaVax™, has successfully completed enrollment and vaccination of the prostate cancer patients and is collecting long-term follow-up results for the 1a portion of their Phase 1a/1b clinical trial. Due to the impressive results and proven safety profile of ProscaVax™, OncBioMune is forgoing the 1b portion of the trial to advance ProscaVax™ into Phase 2 studies. A Phase 2 trial is scheduled to commence at Beth Israel Deaconess Medical Center a Harvard University teaching hospital evaluating ProscaVax as a front-line therapy in prostate cancer patients in the “active surveillance” category, representing the first mid-stage trial of an immunotherapeutic vaccine in this patient population. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals’ need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical’s vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
OncBioMune Pharmaceuticals, Inc.Jonathan F. Head, PhDChief Executive Officer and Chairman of the BoardJhead@oncbiomune.com