OncBioMune Pharmaceuticals, Inc. Provides Latest Clinical Data of ProscaVax
January 26, 2017 at 08:47 pm
Share
OncBioMune Pharmaceuticals, Inc. provided the latest clinical data of ProscaVax, the company's novel therapeutic prostate cancer vaccine. In the ongoing Phase 1 clinical trial, ProscaVax is being evaluated for safety and efficacy in prostate specific antigen (PSA) recurrent prostate cancer in hormone-naïve and hormone-independent patients. Per protocol, 20 patients are expected to be enrolled in the 1a portion of the study, with therapy consisting of six ProscaVax induction vaccinations at a single dose. To date, 16 prostate cancer patients have enrolled in the trial. Additional preliminary data from the trial shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include: 15 of 20 patients* in the Phase 1a portion of the trial have received at least one vaccine injection and 14 patients have received all 6 vaccines. None of the 15 patients who have had at least one vaccine have had a DLAE. None of the 14 patients who have received all 6 vaccines in the Phase 1a have had a DLAE. 9 of the 14 patients that have received 6 vaccines have had increased PSA doubling time, suggesting ProscaVax is slowing tumor growth. 11 of the 13 patients** that have received 6 vaccines have had increased immune responses to PSA as determined with a Lymphocyte Blastogenesis Assay by 31 weeks post-vaccine. 3 of the 14 patients that have received all 6 vaccines have experienced disease progression (one radiological, two PSA). Data from this trial combined with previous in-house studies have established a strong safety profile for ProscaVax, while providing evidence of a therapeutic benefit that warrants larger clinical trials. OncBioMune is preparing to enter a Phase 2/3 trial in Mexico through a Joint Venture with its acquisition target and Mexican partner Vitel Laboratorios S.A. de C.V. Inclusion criteria for the Phase 2/3 trial will be similar to the ongoing Phase 1 trial. A second Phase 2 trial is planned in the United States at a prominent Northeast university cancer center evaluating ProscaVax at disease presentation in early-stage prostate cancer patients in the "active surveillance" population.
Theralink Technologies, Inc. is a proteomics-based, precision medicine company. The Company's technology, through its patented phosphoprotein and protein biomarker platform and lab developed tests (LDTs), targets multiple areas of oncology and drug development. Its LDT, the Theralink Assay for Breast Cancer, is utilized by oncologists across the United States to assist in making the targeted treatment plan for their patients with advanced breast cancer. The Company is also working on a second assay for advanced breast cancer that is planned to be pan-tumor for solid tumors across multiple tumor types, such as ovarian, endometrial, liver, head and neck, colorectal, lung, and prostate, among others. It provides precision oncology data through its Theralink Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both Food and Drug Administration approved and investigational drug treatments.