Regen BioPharma Announces HemaXellerate I(TM) Efficacy Data in Animal Model of Aplastic Anemia
December 11 2013 - 9:35AM
Marketwired
Regen BioPharma Announces HemaXellerate I(TM) 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: Bio-Matrix Scientific Group, Inc. and Regen BioPharma
Inc. David R. Koos, PhD Chairman & Chief Executive Officer
619-702-1404 www.regenbiopharma.com