Bio-Matrix Scientific Group's Regen BioPharma Submits Response to FDA Questions Regarding HemaXellerate Clinical Program
June 07 2013 - 8:30AM
Marketwired
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.
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