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OncBioMune Signs Work Order for Phase 2 Clinical Trial of ProscaVax for Late Stage Prostate Cancer
BATON ROUGE, La., Oct. 16, 2018 (GLOBE NEWSWIRE) -- OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy 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 Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA-Recurrent Prostate Cancer in Hormone-Naïve Patients.” The trial, expected to enroll 30 patients, is being hosted At Urology Clinics of North Texas, a ten center 40 physician practice with 12 physicians honored with inclusion in the peer-selected “The Best Doctors in America” list.
“We’re extremely pleased to have Theradex once again working with us on the further 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. We expect to treat our first patient in early December.”
OncBioMune has submitted the protocol to the FDA and expects a quick review by the outside IRB. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, with the expectation that the summary of the clinical 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 “biochemical progression,” a disease state with few management options. The goal of treating the recurrent prostate cancer patients with ProscaVax is to inhibit the progression of the disease and prevent or delay treatment with more toxic therapies.
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 therapeutic cancer 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 clinical trials A Phase 2 clinical 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