Regen BioPharma Narrows Selection of CRO Candidates for HemaXellerate GLP Safety Studies Requested by the FDA
Company Expects to Make a Final Decision on CRO Shortly; GLP Safety Study Believed to Be Last Hurdle in IND Process With FDA Before Commencing Clinical Trials
SAN DIEGO, CA--(Marketwired - Apr 13, 2015) - Regen BioPharma Inc. (OTCBB: RGBP), (OTC PINK: RGBP) announced today that it has narrowed the Contract Research Organization (CRO) selection process to two candidates. The selected candidate will conduct the HemaXellerate Good Laboratory Practice (GLP) safety study requested by the US Food and Drug Administration ( FDA). This study will consist of an additional set of animal safety studies on HemaXellerate in preparation for submission to the FDA for permission to initiate "First in Human" use of HemaXellerate. HemaXellerate is a proposed therapeutic product for treating aplastic anemia.
The FDA, which granted Regen IND #15376, requested Regen perform one experiment utilizing Good Laboratory Practices (GLP) before clinical trials can be initiated. Based on written and telephonic discussions with the FDA, Regen believes that once these experiments are completed, it will be given permission to initiate a 10 patient trial of its HemaXellerate therapy patients resistant traditional aplastic anemia therapies.
"Currently patients with aplastic anemia who have failed immune suppressive treatments and lack a bone marrow match have no therapeutic options," said Thomas Ichim, Ph.D., Chief Scientific Officer. "We are highly optimistic in obtaining positive results from the safety studies given that these studies are repetition of previous data that we submitted, which were performed in the academic laboratory setting."
HemaXellerate is a personalized therapeutic product derived from patient adipose tissue which has been demonstrated to repair damaged bone marrow by stimulation of a regenerative process in the cells responsible for maintaining blood production. Animal studies have demonstrated that HemaXellerate treatment is capable of accelerating healing of bone marrow cells that were previously damaged in response to agents that are toxic to the bone marrow and cause a biological process resembling aplastic anemia.
"We anticipate completing the CRO selection process by the end of next week," said David Koos, Chairman & CEO of Regen. "Entry of HemaXellerate into the clinic will not only provide a possible treatment to address a current Orphan unmet medical need, but will also allow the development of HemaXellerate as a candidate for addressing the issue of low white blood cell production, which is a multi-billion dollar market."
ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.
Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
CONTACT INFORMATION
CONTACT INFORMATION
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
619-702-1404 Phone
619-330-2328 Fax
www.regenbiopharma.com
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