OncBioMune Announce Latest Data From Phase 1 Trial of ProscaVax for Prostate Cancer

OncBioMune Pharmaceuticals (OTCMKTS:OBMP), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, is pleased to provide the latest information from the Phase 1 clinical trial evaluating the Company’s novel cancer vaccine, ProscaVax, in PSA (Prostate Specific Antigen) recurrent prostate cancer in both hormone-naïve and hormone-independent patients. The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under an IND from the U.S. Food and Drug Administration with funding from the U.S. Navy Cancer Vaccine Program.
To date, 16 patients have been enrolled in the Phase 1a trial. A strong safety profile has been established for ProscaVax. No serious adverse events have been reported in the trial, further validating prior research in hundreds of patients showing minimal toxicity of the Company’s vaccine technology.
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 dose limiting adverse event (DLAE)
• None of the 14 patients who have received all 6 vaccines in the Phase 1a have had a DLAE
• 9 of the 12 patients (75%) who have received 6 vaccines have had increased immune responses to PSA as determined with a LBA (lymphocyte blastogenesis assay)
• 9 of 11 patients (82%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA
• Three of the 14 patients who have received all 6 vaccines have experienced disease progression (one radiological, two PSA)

The trial was originally designed as a Phase 1a/1b study with approximately 20 patients expected to be enrolled in the Phase 1a portion. As previously disclosed, based upon encouraging preliminary data, OncBioMune is foregoing the Phase 1b portion of the trial and advancing into a larger Phase 2/3 trial of ProscaVax through a Joint Venture with Vitel Laboratorios S.A. de C.V. in Mexico that will be similar in design in evaluating ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. OncBioMune is pleased to inform shareholders that this trial remains on schedule for enrollment to commence this quarter.
Separately, OncBioMune is working to initiate a Phase 2 trial of ProscaVax in early-stage prostate cancer patients in the “active surveillance” stage of disease at a prominent university in the Northeast United States.
“We now have more data from the Phase 1 trial with a median follow up of 30 months, showing that ProscaVax has provided a safe, significant benefit to these late-stage prostate cancer patients with respect to increased immune response to PSA,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Given that there is ample data demonstrating the safety and therapeutic benefit of ProscaVax, we are moving into Phase 2/3 trials, where we are confident that enrollment will progress at a quicker pace. As often happens, a Phase 1 trial moves a little more slowly than expected, but the data is very compelling and leaves us excited about moving forward with mid-stage studies.”
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