Bio-Matrix Scientific Group Inc.'s Regen BioPharma Submits Response to FDA Questions Regarding HemaXellerate Clinical Program
Published: Jun 07, 2013
SAN DIEGO, CA--(Marketwired - June 07, 2013) - Regen BioPharma, wholly owned subsidiary of Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN), announced today its submission of responses to the U.S. Food and Drug Administration's (FDA) comments regarding its IND # 15376 covering the use of HemaXellerate for treatment of immune suppressant resistant aplastic anemia. As part of the response to comments, Regen BioPharma provided new data demonstrating efficacy of the HemaXellerate product at accelerating stem cell recovery after chemotherapeutic injury.
"We are pleased with the responses that we have provided to the FDA and look forward to initiating our clinical trials," stated David Koos, Chairman and CEO of Regen BioPharma. "Although it is possible that a second round of comments may be issued, we feel this process is extremely useful to creating a clinical trial that is optimized for safety and detection of efficacy."
The HemaXellerate clinical trial aims to recruit 10 patients with aplastic anemia that have not shown material signs of improvement under the current the standard of care. If successful, the company will progress to larger efficacy-finding trials, as well as expansion to other diseases that would benefit from enhancement of bone marrow stem cells.
The scientific rationale for HemaXellerate, as well as some of the supporting data, may be found in the peer reviewed publication titled "Exogenous endothelial cells as accelerators of hematopoietic reconstitution," which is available at this link http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf
Currently there is a need for therapies that stimulate bone marrow stem cells. HemaXellerate utilizes cells derived from the patient's own fat stem cells to repair and stimulate the hematopoietic stem cells of the bone marrow, which are responsible for production of blood. The current market for therapies that stimulate blood cell production is in the billions of dollars per year. Neupogen and Neulasta, two products that stimulate production of white blood cells had sales of $4.84 Billion in 2010 http://www.wikinvest.com/stock/Amgen.
About Bio-Matrix Scientific Group, Inc. and Regen BioPharma, Inc.:
Bio-Matrix Scientific Group, Inc. (OTCQB: 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
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