Regen BioPharma Receives IND From FDA for HemaXellerate
Published: Mar 18, 2013
SAN DIEGO, CA--(Marketwire - March 18, 2013) - Regen BioPharma, Inc., a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: BMSN), announced today issuance of IND number 15376 for its proposed Phase I/II clinical trial evaluating use of its stem cell product, HemaXellerate, for treatment of aplastic anemia.
As part of the clinical trial approval process, the FDA will issue comments on the proposed trial which must be addressed to the FDA's satisfaction before patient dosing is initiated. The clinical trial will treat ten patients with aplastic anemia that have not responded to conventional therapy and lack a bone marrow donor.
"We are pleased that the company has been issued an IND number and has taken the first step towards regulatory approval in the USA," said David Koos, Chairman & CEO of Bio-Matrix. "We have compiled an internationally-renowned team, consisting of corporate and academic partners, which cover the manufacturing, regulatory, and medical aspects of the project. Members of the team have previously published with Regen the scientific rational for the trial in a peer-reviewed publication in January of last year which may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf."
HemaXellerate is a patient-specific composition of cells that have previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. If the clinical trial is successful, the company plans to expand use of HemaXellerate™ to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market. This market is substantial in size and currently includes drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®.
About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:
Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN) through its wholly owned subsidiary, Regen BioPharma, Inc., is a biotechnology company focused on identifying undervalued regenerative medicine patents in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/II clinical trials. To follow our development, visit us at www.regenbiopharma.com.
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