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Press Release

70% of Advanced Prostate Cancer Patients Treated with ProscaVax Demonstrate Improvement in PSA Doubling Time


Posted on: 10 Jan 18

BATON ROUGE, La., Jan. 10, 2018 (GLOBE NEWSWIRE) -- OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, today announces the latest follow-up data from the Company’s Phase 1a trial of ProscaVax for prostate cancer.  ProscaVax is OncBioMune's novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

In the trial, 20 hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA were treated with six intradermal injections of ProscaVax.

The latest data shows:

  1. 14 of 20 (70%) patients have increased PSA Doubling Time (PSADT – the time for serum PSA to double its value and a key metric of disease progression) post-initiation of ProscaVax immunotherapy. This demonstrates a slowing of tumor growth at a minimum of 31 weeks post-initiation of ProscaVax immunotherapy.
  2. 15 of 18 patients have increased immunity to PSA at 31 weeks post-initiation of ProscaVax immunotherapy.
  3. Of the 20 patients that completed ProscaVax immunotherapy, 4 patients have shown disease progression at 31 weeks and one patient has chosen to withdraw from the study after week 19 without progression and entered another clinical trial.
  4. As a subset, of the four patients that demonstrated disease progression at 31 weeks, 3 did not have an increase in their PSADT.

“This data continues to build upon an impressive data set from the study indicating that ProscaVax is inhibiting prostate cancer progression in patients that have failed today’s standard therapies.  There is a body of evidence in relapsed and advanced prostate cancer patients that slowing the velocity of PSA increase and therefore increasing PSA doubling time has a significant impact on improving prognoses,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “In my view, not only would a therapy that can increase PSADT in a majority of patients obviously be extremely valuable in the therapeutic sense, but there is the possibility that monitoring PSADT can help identify patients that may require additional more aggressive treatment regimens due to inability to decrease PSA velocity.  We look forward to mid-stage studies to better understand the clinical benefit of ProscaVax and the opportunity to improve clinical care in this area of unmet medical need.”

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About OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, including a proprietary vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. Our lead pipeline product, ProscaVax™, has successfully completed enrollment and vaccination of the prostate cancer patients and is collecting long-term follow-up results for the 1a portion of their Phase 1a/1b clinical trial.  Due to the impressive results and proven safety profile of ProscaVax™, OncBioMune is forgoing the 1b portion of the trial to advance ProscaVax™ into Phase 2 studies.  A Phase 2 trial is scheduled to commence at a major Northeast U.S. university cancer research hospital evaluating ProscaVax as a front-line therapy in prostate cancer patients in the “active surveillance” category, representing the first mid-stage trial of an immunotherapeutic vaccine in this patient population.  OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.

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. 

Contact:

OncBioMune Pharmaceuticals, Inc.
Andrew Kucharchuk
President and Chief Financial Officer
akucharchuk@oncbiomune.com

GlobeNewswire
globenewswire.com

Last updated on: 11/01/2018

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