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OncBioMune Continuing Phase 1 Trial, While Initiating Phase 2 Trial of ProscaVax for Prostate Cancer
OncBioMune Continuing Phase 1 Trial, While Initiating Phase 2 Trial of ProscaVax for Prostate Cancer.
About this update from Theralink Technologies Inc.
[{"type":"text","content":"\nOncBioMune Continuing Phase 1 Trial, While Initiating Phase 2 Trial of ProscaVax for Prostate Cancer \n\nOncBioMune Continuing Phase 1 Trial, While Initiating Phase 2 Trial of ProscaVax for Prostate Cancer\n\n\n BATON ROUGE, LA--(Marketwired - February 23, 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, is pleased to report positive results from its Phase 1 clinical trial of ProscaVax, the Company's novel cancer vaccine for prostate cancer. The trial is hosted at the University of California San Diego Moores Cancer Center and the Veterans' Hospital, La Jolla, CA to evaluate the safety and efficacy of ProscaVax in patients with recurrent disease, defined as rising PSA after initial treatment (surgery, radiation, or brachytherapy/radioactive seeds).The trial was originally designed as a Phase 1a/1b study with an estimated enrollment of 20 patients in the Phase 1a and 28 in the Phase 1b. Fifteen patients have been enrolled in the Phase 1a portion of the trial. Preliminary data collected from the trial to date supports data from previous clinical research, showing that ProscaVax has a very strong safety profile. No serious adverse events have ever been reported in any clinical study relating to the vaccine technology. Additional preliminary data shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:\n 14 of 20 patients in the Phase 1a portion of the trial have received at least one vaccine injection and 12 patients have received all 6 vaccines\n None of the 14 patients who have had at least one vaccine have had a dose limiting adverse event (DLAE)\n None of the 12 patients who have received all 6 vaccines in the Phase 1a have had a DLAE\n 8 of the 12 patients (66.7%) who have received 6 vaccines have had increased immune responses to PSA as determined with a LBA\n 8 of 11 patients (72.7%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA\n Based upon the lack of toxicity and compelling immunological data collected, OncBioMune is continuing the Phase 1a trial and incorporating the Phase 1b of ProscaVax into a Phase 2 trial ...