SAN DIEGO, Jul. 9, 2015 /PRNewswire/ --Regen BioPharma, Inc. (OTCBB: RGBP) (OTC: RGBP) reported today the successful dosing of mice lacking an immune system in a safety and tolerability study with HemaXellerate, the Company's proprietary aplastic anemia cell therapy drug candidate. The experiment is being conducted under Good Laboratory Practices (cGLP) by Charles River Laboratories. Charles River Laboratories, established in 1947, is a well respected NYSE-traded contract research organization with 8,500 employees specializing in a variety of pre-clinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries.
The purpose of the study is to evaluate whether administration of more than ten-fold the proposed clinical dose of cells in mice on a per weight basis will cause any adverse effects on the experimental mice. The study was conducted in response to the last material question posed by the US Food and Drug Administration ("FDA") to Regen with regard to Regen's proposed clinical trial evaluating HemaXellerate in patients with aplastic anemia.
"Given that HemaXellerate is generated from the patient's own fat (adipose) tissue, we are highly optimistic that no adverse effects will be observed." Stated Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma. "It was important to conduct this study in mice lacking an immune system because we will be administering human cells. The immune deficient mice provide an excellent and trusted model of evaluating human cell therapies in the rodent system."
Safety parameters evaluated will include: weight changes, alteration in cellular structures of the major organs, organ function, serum biochemistry, and hematology tests. The initial observation will take 14 days, after which data will be collected, analyzed, and submitted to the FDA. Charles River Laboratories anticipates submission to Regen BioPharma, Inc. of an audited draft report by September 16, 2015.
"We are confident that these experiments mark the last stage of experiments we will be required to conduct prior to obtaining clearance from the FDA to initiate the proposed clinical trial," said David Koos, Chairman & CEO. "It is important to state that the FDA has been very supportive of our work and provided input into the experimental protocol before we initiated these experiments."
ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) (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.
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
SOURCE Regen BioPharma, Inc.