Regen BioPharma Files Investigational New Drug (IND) Application With FDA on HemaXellerate I(TM) Stem Cell Drug for Aplastic ...
February 05 2013 - 10:35AM
Marketwired
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
™ stem cell drug in patients with drug-refractory
aplastic anemia.
HemaXellerate I™ 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™ 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™ 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™ 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®.
"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™
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™ 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
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