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Enrollment to Begin in OncBioMune's Trial of ProscaVax for Prostate Cancer in Mexico
Enrollment to Begin in OncBioMune's Trial of ProscaVax for Prostate Cancer in Mexico.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nEnrollment to Begin in OncBioMune's Trial of ProscaVax for Prostate Cancer in Mexico\n\nEnrollment to Begin in OncBioMune's Trial of ProscaVax for Prostate Cancer in Mexico\n\nBATON ROUGE, LA--(Marketwired - June 27, 2017) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (\"OncBioMune\" or the \"Company\"), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, today announces that the Company has been advised that the Mexico health authority, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) is officially authorizing commencement of the study. OncBioMune is working with the host hospital, principal investigators and others involved in the trial to begin enrollment immediately.\"This is what we've been waiting for and we greatly look forward to enrolling the first patient in the trial in our bid to fill an unmet medical need in Mexico,\" commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. \"Unfortunately, the more than 300,000 Mexican men diagnosed with prostate cancer each year have limited therapeutic options and none without a high degree of risk of morbidities. We hope to change that with ProscaVax, which we believe will reproduce the strong safety and efficacy profiles that we saw in the Phase 1 study at the University of California San Diego.\"In the study, OncBioMune's immunotherapeutic vaccine, ProscaVax, will be evaluated in prostate specific antigen (PSA) recurrent prostate cancer in hormone-naïve and hormone-independent patients. 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. The Phase 3 portion will enroll 50 additional patients and is expected to commence 12 months after the Phase 2 begins. Patients in this portion of the trial will receive six vaccines as well as an 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 commer...