Bio-Matrix Scientific Group Inc.'s Subsidiary Regen BioPharma Enters Into Preclinical Trials Agreement for HemaXellerate I Covering Aplastic Anemia
Published: Sep 26, 2013
SAN DIEGO, CA--(Marketwired - September 26, 2013) - Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) announced today its subsidiary Regen BioPharma Inc. signed an agreement with Dr. Wei-Ping Min covering experiments requested by the FDA in support of clearance for the company's IND #15376 for use of HemaXellerate I in the treatment of drug refractory aplastic anemia.
Regen BioPharma filed an Investigational New Drug (IND) application for HemaXellerate I in February 2013 seeking permission from the FDA to initiate a ten patient clinical trial. The FDA reviewed the Company's IND application and had a series of questions, which the company responded to on June 7th. The first series of comments were related to the manufacturing of HemaXellerate I and were successfully addressed. Subsequently the FDA responded with a second series of comments relating to cellular responses in mouse models of aplastic anemia. Regen BioPharma has been in discussions with Dr. Wei-Ping Min, who also sits on the company's scientific advisory board regarding responding to the FDA comments. On September 24th, Dr. Min signed a services agreement for conducting the animal studies requested by the FDA.
"Having worked in an advisory capacity with Regen BioPharma for more than a year now, I am excited to increase my involvement and lead the experiments needed to respond to the FDA questions," said Dr. Wei-Ping Min. "As an immunologist, the concept of using patient-specific fat derived tissue as the basis for modulating the immune system in patients with aplastic anemia is very enticing. I look forward to working with Regen in developing HemaXellerate for use in patients suffering from this devastating disease who have no treatment options."
"Dr. Min is considered an internationally-recognized pioneer in the area of cell therapy and immunology. We look forward to leveraging his expertise in accelerating the clinical development of our First in Class product for aplastic anemia," noted the Company's Chairman & CEO David Koos.
About Regen BioPharma: Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. For more information refer to the company's website http://www.regenbiopharma.com/
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.
Bio-Matrix Scientific Group, Inc. and
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
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