Regen BioPharma Receives IND # From FDA for HemaXellerate
March 18 2013 - 9:57AM
Marketwired
Regen BioPharma, Inc., a wholly-owned subsidiary of Bio-Matrix
Scientific Group Inc. (PINKSHEETS: BMSN), announced today issuance
of IND number 15376 for its proposed Phase I/II clinical trial
evaluating use of its stem cell product, HemaXellerate, for
treatment of aplastic anemia.
As part of the clinical trial approval process, the FDA will
issue comments on the proposed trial which must be addressed to the
FDA's satisfaction before patient dosing is initiated. The clinical
trial will treat ten patients with aplastic anemia that have not
responded to conventional therapy and lack a bone marrow donor.
"We are pleased that the company has been issued an IND number
and has taken the first step towards regulatory approval in the
USA," said David Koos, Chairman & CEO of Bio-Matrix. "We have
compiled an internationally-renowned team, consisting of corporate
and academic partners, which cover the manufacturing, regulatory,
and medical aspects of the project. Members of the team have
previously published with Regen the scientific rational for the
trial in a peer-reviewed publication in January of last year which
may be found at
http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf."
HemaXellerate 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. If the clinical trial is successful, the company plans to
expand use of HemaXellerate™ 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®.
About Bio-Matrix Scientific Group Inc. and
Regen BioPharma, Inc.:
Bio-Matrix Scientific Group, Inc. (PINKSHEETS: 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