SOURCE: Bio-Matrix Scientific Group, Inc.

December 11, 2013 09:35 ET

Regen BioPharma Announces HemaXellerate I™ Efficacy Data in Animal Model of Aplastic Anemia

Ongoing Experiments Support Planned Response to FDA Questions for IND #15376

SAN DIEGO, CA--(Marketwired - Dec 11, 2013) - Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) announced today results of ongoing experiments in collaboration with Dr. Wei-Ping Min of the University of Western Ontario using HemaXellerate I to treat an immune competent animal model of aplastic anemia.

The HemaXellerate I study utilized mice that were bone marrow compromised, in a similar manner to bone marrow damage in patients with aplastic anemia. Subsequently animals were treated with increasing doses of HemaXellerate I. A dose-dependent increase in bone marrow repair was noted, as observed by acceleration of blood cell production after treatment with the chemotherapeutic agent. In contrast to previous experiments reported by the company, in this set of experiments, recipient animals possessed an intact immune system, implying that the HemaXellerate I product does not trigger adverse immune reactions.

"These data are part of the FDA requested experiments, which we are compiling to address the second series of questions that the FDA has asked us subsequent to our filing of IND #15376 for use of HemaXellerate I in the treatment of drug refractory aplastic anemia." Said David Koos, CEO of Regen. "By leveraging our SAB members, collaborators such as Dr. Wei-Ping Min, and contractors such as Cook General Biotechnology, who manufactures GMP-grade HemaXellerate I, the Company believes it is well positioned to develop the product as the first regenerative medicine solution for drug resistant aplastic anemia, an indication which qualifies for Orphan Drug Status."

Regen's focus on aplastic anemia is based on the ability of specific cells from the lining of blood vessels to stimulate repair of injured bone marrow stem cells, which are responsible for production of blood cells. The rationale for this product was published in a peer-reviewed publication by Regen last year, which is available freely at http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.

"Our group is optimistic about the results announced today, and we are in the process of conducting additional safety studies requested by the FDA before initiation of clinical trials," stated Dr. Wei-Ping Min, Professor at the University of Western Ontario, Canada. "The finding of efficacy of HemaXellerate in an immune competent recipient is intriguing and suggests this cellular product is relatively innocuous from an immunological perspective."

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.

Contact Information

  • Contact:

    Bio-Matrix Scientific Group, Inc. and
    Regen BioPharma Inc.
    David R. Koos, PhD
    Chairman & Chief Executive Officer
    619-702-1404
    www.regenbiopharma.com