On October 16, 2018 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, reported 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 (Press release, Oncbiomune, OCT 16, 2018, View Source [SID1234530471])." 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.
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"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.