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Patients Pre-Screened for OncBioMune Pharmaceuticals Phase 2/3 Trial of ProscaVax for Prostate Cancer
Patients Pre-Screened for OncBioMune Pharmaceuticals Phase 2/3 Trial of ProscaVax for Prostate Cancer.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nPatients Pre-Screened for OncBioMune Pharmaceuticals Phase 2/3 Trial of ProscaVax for Prostate Cancer\n\nPatients Pre-Screened for OncBioMune Pharmaceuticals Phase 2/3 Trial of ProscaVax for Prostate Cancer\n\nBATON ROUGE, LA--(Marketwired - December 28, 2016) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (\"OncBioMune\" or the \"Company\"), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, today announces that the Company has been advised that approximately 30 patients have been pre-screened to participate in the Phase 2/3 trial of ProscaVax for prostate cancer in Mexico. The trial is being conducted through a Joint Venture between OncBioMune and the Company's Mexico-based acquisition target, Vitel Laboratorios, S.A. de C.V. (\"Vitel\").In the study, ProscaVax, OncBioMune's lead experimental therapeutic cancer vaccine, will be evaluated for safety and efficacy in PSA (prostate specific antigen) recurrent prostate cancer in hormone-naïve and hormone-independent patients. OncBioMune has been further advised that administration of ProscaVax to trial participants is expected to commence shortly after the first of the new year.The trial is scheduled to enroll 50 patients in the Phase 2 portion. Patients will receive six vaccines of ProscaVax, a combination of the tumor-associated antigen PSA with the biological adjuvants IL-2 and GM-CSF. Under the guidance of regulatory authorities, the Phase 3 portion will enroll 50 additional patients and commence 12 months after the Phase 2 begins. Patients in this portion of the trial will receive six vaccines as well as additional booster regimen of ProscaVax. The trial's endpoints will be reduction in PSA progression and increased immune responses post-vaccination.Contingent upon clinical results meeting expectations in demonstrating safety and efficacy, OncBioMune intends to seek commercialization of ProscaVax in Mexico through a Preliminary Marketing Authorization, which has the potential to happen in as little as 24 months from the commencement of the Phase 2 study, according to OncBioMune's Mexican advisors.Prostate cancer is the most frequently diagnosed type of cancer in male patients over 50 years in age in Mexico. Annually, in excess of 300,000 Mexican men are diagnosed with prostate cancer and...