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OncBioMune Advancing ProscaVax Towards Second Phase 2 Clinical Trial for Prostate Cancer with Protocol Submission to FDA
BATON ROUGE, La., Oct. 11, 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, is pleased to announce that the protocol for the planned Phase 2 clinical trial of ProscaVax for advanced prostate cancer to be hosted at Urology Clinics of North Texas (UCNT) has been submitted to the U.S. Food and Drug Administration for approval to initiate the study. We expect the FDA and IRB process to move quickly and have the first patient injected before the first of December.
The trial is designed to build upon a successfully completed Phase 1a trial of ProscaVax in patients with advanced prostate cancer that have failed previous therapy with documented rising prostate specific antigen (PSA). In the Phase 1a trial, ProscaVax, the Company’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), was shown to be safe and well tolerated.
At 19 weeks post-therapy, 80 percent of patients (n=20) in the Phase 1a trial demonstrated stable disease/no prostate cancer progression. Of those 16 patients, 12 completed additional follow-up examinations at 43 weeks post-therapy. Overall survival was 100% for all 20 patients and 12 of the 17 evaluable patients (70.6%) continued to live with stable/progression-free disease.
The latest study is structured to expeditiously add to the body of clinical evidence supporting the safety and efficacy of ProscaVax by using an independent Institutional Review Board and accessing for enrollment the large population of prostate cancer patients being treated at UCNT. UCNT is a premier urology group with ten centers in North Texas and a team that includes 12 physicians honored with inclusion in the peer-selected “The Best Doctors in America” list.
“We are thrilled to be working with the esteemed prostate cancer experts at UCNT and to have completed all necessary negotiations and protocol finalizations to move towards a second clinical trial of ProscaVax in late-stage patients. We believe that ProscaVax will again be able to deliver a meaningful therapeutic benefit to these patients with advanced disease that currently are presented with almost no safe and effective options,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Combined with the initiation of the world’s first ever study of a vaccine in early-stage prostate cancer patients in ‘active surveillance’ at a teaching hospital of Harvard University, we are steadily building our position as a leader in immunotherapy with a novel approach to prostate cancer. As we grow this footprint, we believe that there will be an increase in our market valuation followed by potential partnering opportunities.”
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 20 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, PhD
Chief Executive Officer and Chairman of the Board