Regen BioPharma Files Investigational New Drug (IND) Application With FDA on HemaXellerate I(TM) Stem Cell Drug for Aplastic Anemia

Tue Feb 5, 2013 10:35am EST

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  SAN DIEGO, CA, Feb 05 (Marketwire) -- 
Regen BioPharma a wholly-owned subsidiary of Bio-Matrix Scientific Group
Inc. (PINKSHEETS: BMSN), announced today filing of an Investigational New
Drug (IND) application with the FDA to initiate clinical trials assessing
the company's HemaXellerate I(TM) stem cell drug in patients with
drug-refractory aplastic anemia. 

    HemaXellerate I(TM) 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. The company,
together with an internationally-renowned group of stem cell researchers,
recently published the scientific basis for the HemaXellerate I(TM)
product which may be found at
http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf. 

    "Currently patients with aplastic anemia who are resistant to drugs and
ineligible for bone marrow transplant have no therapeutic options. We are
fortunate to be in the position to have developed a novel approach to
potentially treat this terrible condition," said David Koos, CEO of
Bio-Matrix. "To our knowledge the HemaXellerate I(TM) product is the only
therapy that has potential to simultaneously block the underlying cause
of aplastic anemia while at the same time rebuilding the bone marrow
tissue that has been damaged by the disease."

    If the clinical trial is successful, the company plans to expand use of
HemaXellerate I(TM) 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(R), Neulasta(R), Leukine(R) and Revolade(R). 

    "Current drug-based approaches for healing bone marrow damage involve
"flooding" the body with growth factors, which is extremely expensive and
causes unintended consequences because of lack of selectivity," said Dr.
Vladimir Bogin, CEO of Chromos Pharma (a contract research organization),
which collaborated with Regen on filing the IND and member of the
Company's Scientific Advisory Board. "Based on our data HemaXellerate
I(TM) possesses the advantage delivering an optimized cellular mixture
that produces the needed growth factors at the specific location in the
bone marrow niche."

    The planned clinical trial anticipates recruiting 10 patients who have
failed standard of care, which will be treated with HemaXellerate I(TM)
and followed for safety parameters and signals of efficacy. Therapeutic
effects will be quantified based on immunological measurements, as well
as improvement in blood counts. Patients in the trial will be assessed
for one year, however, because the trial is unblinded, data will be
available as the study progresses.

    About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.: 

    Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN) is a biotechnology
company developing regenerative medicine therapies. The Company is
focused on human therapies that address unmet medical needs.
Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the
quality of life through therapies involving stem cell treatments. These
treatments are focused in areas relating to cardiovascular, hematology,
oncology and other indications. 

    Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc.
(PINKSHEETS: BMSN), 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. 

    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. 
David R. Koos, PhD
Chairman & Chief Executive Officer
619-702-1404
www.bmsn.us
dkoos@bmsn.us 

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