Bio-Matrix Scientific Group's Subsidiary Regen BioPharma Enters Into Preclinical Trials Agreement for HemaXellerate I Coverin...
26 September 2013 - 10:00PM
Marketwired
Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) announced today its
subsidiary Regen BioPharma Inc. signed an agreement with Dr.
Wei-Ping Min covering experiments requested by the FDA in support
of clearance for the company's IND #15376 for use of HemaXellerate
I in the treatment of drug refractory aplastic anemia.
Regen BioPharma filed an Investigational New Drug (IND)
application for HemaXellerate I in February 2013 seeking permission
from the FDA to initiate a ten patient clinical trial. The FDA
reviewed the Company's IND application and had a series of
questions, which the company responded to on June 7th. The first
series of comments were related to the manufacturing of
HemaXellerate I and were successfully addressed. Subsequently the
FDA responded with a second series of comments relating to cellular
responses in mouse models of aplastic anemia. Regen BioPharma has
been in discussions with Dr. Wei-Ping Min, who also sits on the
company's scientific advisory board regarding responding to the FDA
comments. On September 24th, Dr. Min signed a services agreement
for conducting the animal studies requested by the FDA.
"Having worked in an advisory capacity with Regen BioPharma for
more than a year now, I am excited to increase my involvement and
lead the experiments needed to respond to the FDA questions," said
Dr. Wei-Ping Min. "As an immunologist, the concept of using
patient-specific fat derived tissue as the basis for modulating the
immune system in patients with aplastic anemia is very enticing. I
look forward to working with Regen in developing HemaXellerate for
use in patients suffering from this devastating disease who have no
treatment options."
"Dr. Min is considered an internationally-recognized pioneer in
the area of cell therapy and immunology. We look forward to
leveraging his expertise in accelerating the clinical development
of our First in Class product for aplastic anemia," noted the
Company's Chairman & CEO David Koos.
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 Follow us on Twitter
at: https://twitter.com/RegenBioPharma