BATON ROUGE, La. , Feb. 26, 2018 (GLOBE NEWSWIRE
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Posted On: 02/26/2018 1:14:44 PM
BATON ROUGE, La. , Feb. 26, 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 provides an update on the status of the two planned clinical trials of ProscaVax for prostate cancer. ProscaVax is OncBioMune’s lead immunotherapy candidate 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). The Company has successfully completed a Phase 1a clinical trial of ProscaVax in hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA and the patients continue to be followed for additional endpoints.
OncBioMune is moving forward with two separate clinical trials evaluating ProscaVax. One clinical trial is in advanced cancer patients in conjunction with the Urology Clinics of North Texas (“UCNT”) and the second is front-line therapy in early-stage cancer patients, which is to be hosted at a teaching hospital of Harvard University Medical School in Boston, MA.
With respect to the Phase 2 clinical trial hosted by UCNT, the company is preparing the protocol for FDA submission. For FDA approval the company will use a central IRB ( Institutional Review Board ), as central IRBs move much faster than most university IRBs.
As for the Phase 2 clinical trial at the Harvard University teaching hospital, the Protocol has been approved by the Nursing Committee, Pharmacists, the Regulatory Committee and is under review by the Scientific Review Committee. After approval patient enrollment will begin.
Company Chief Financial Officer Andrew Kucharchuk added, “We are excited to be building such great momentum in 2018. Having a clinical trial in both early and late stage prostate cancer that will be enrolling patients in the coming months, combined with the progress we are making on our other platform therapies, particularly OvcaVaxTM, shows we are moving full speed ahead in 2018.
Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.
About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, based on their 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 Harvard University teaching 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. Jonathan Head , Phd Chief Executive officer and Chairman Jhead@oncbiomune.com
, a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, today provides an update on the status of the two planned clinical trials of ProscaVax for prostate cancer. ProscaVax is OncBioMune’s lead immunotherapy candidate 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). The Company has successfully completed a Phase 1a clinical trial of ProscaVax in hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA and the patients continue to be followed for additional endpoints. OncBioMune is moving forward with two separate clinical trials evaluating ProscaVax. One clinical trial is in advanced cancer patients in conjunction with the Urology Clinics of North Texas (“UCNT”) and the second is front-line therapy in early-stage cancer patients, which is to be hosted at a teaching hospital of Harvard University Medical School in Boston, MA.
With respect to the Phase 2 clinical trial hosted by UCNT, the company is preparing the protocol for FDA submission. For FDA approval the company will use a central IRB ( Institutional Review Board ), as central IRBs move much faster than most university IRBs.
As for the Phase 2 clinical trial at the Harvard University teaching hospital, the Protocol has been approved by the Nursing Committee, Pharmacists, the Regulatory Committee and is under review by the Scientific Review Committee. After approval patient enrollment will begin.
Company Chief Financial Officer Andrew Kucharchuk added, “We are excited to be building such great momentum in 2018. Having a clinical trial in both early and late stage prostate cancer that will be enrolling patients in the coming months, combined with the progress we are making on our other platform therapies, particularly OvcaVaxTM, shows we are moving full speed ahead in 2018.
Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.
About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, based on their 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 Harvard University teaching 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. Jonathan Head , Phd Chief Executive officer and Chairman Jhead@oncbiomune.com
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