On February 26, 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 an update on the status of the two planned clinical trials of ProscaVax for prostate cancer (Press release, Oncbiomune, FEB 26, 2018, View Source [SID1234524354]). ProscaVax is OncBioMune’s lead immunotherapy 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). The Company has successfully completed a Phase 1a clinical trial of ProscaVax in hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA and the patients continue to be followed for additional endpoints.
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OncBioMune is moving forward with two separate clinical trials evaluating ProscaVax. One clinical trial is in advanced cancer patients in conjunction with the Urology Clinics of North Texas ("UCNT") and the second is front-line therapy in early-stage cancer patients, which is to be hosted at a teaching hospital of Harvard University Medical School in Boston, MA.
With respect to the Phase 2 clinical trial hosted by UCNT, the company is preparing the protocol for FDA submission. For FDA approval the company will use a central IRB (Institutional Review Board), as central IRBs move much faster than most university IRBs.
As for the Phase 2 clinical trial at the Harvard University teaching hospital, the Protocol has been approved by the Nursing Committee, Pharmacists, the Regulatory Committee and is under review by the Scientific Review Committee. After approval patient enrollment will begin.
Company Chief Financial Officer Andrew Kucharchuk added, "We are excited to be building such great momentum in 2018. Having a clinical trial in both early and late stage prostate cancer that will be enrolling patients in the coming months, combined with the progress we are making on our other platform therapies, particularly OvcaVaxTM, shows we are moving full speed ahead in 2018.