Latest Data From Phase 1 Trial of ProscaVax for Prostate Cancer Reinforces Safety and Benefit of Novel Cancer Vaccine
Marketwired
BATON ROUGE, LA--(Marketwired - August 08, 2016) - OncBioMune Pharmaceuticals, Inc. (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 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."
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax® is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals' actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals' need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical's vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
