Regen BioPharma, a Majority Owned Subsidiary of Bio-Matrix Scientific Group, Provides Update on HemaXellerate I(TM) IND for T...
May 12 2014 - 12:30PM
Marketwired
Regen BioPharma, a Majority Owned Subsidiary of Bio-Matrix
Scientific Group, Provides Update on HemaXellerate I(TM) IND for
Treatment of Drug Resistant Aplastic Anemia
Company Passes Manufacturing and Clinical Reviewers,
Clarification of Safety Studies Requested by FDA
SAN DIEGO, CA--(Marketwired - May 12, 2014) - Regen BioPharma
Inc., a majority owned subsidiary of Bio-Matrix Scientific Group
Inc. (PINKSHEETS: BMSN), announced today an update on its IND #
15376 for use of HemaXellerate I™ in treatment of patients with
drug refractory aplastic anemia.
On March 6, 2014, Regen submitted a protocol modification,
additional details on manufacturing, and new data to the FDA
regarding therapeutic effects of HemaXellerate I™ in animal models
of diseases similar to aplastic anemia in humans, as well as
additional safety data.
The Company reports the FDA accepted the clinical protocol and
the product manufacturing information provided, however,
clarification on animal safety studies was requested.
"Given the HemaXellerate I™ product is derived from the
patient's own fat tissue, and numerous key opinion leaders support
clinical entry of our product, as demonstrated by our peer reviewed
publication
http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.,
we are confident the safety studies the FDA requested clarification
on can be addressed in a timely fashion," stated Thomas Ichim,
Regen's Chief Scientific Officer and Board Member.
"The role of the FDA is to ensure the highest standards of
safety for new products. We view the requested clarifications
from the FDA in regards to safety studies as part of the normal
process of FDA submission. Given that the HemaXellerate I™
possesses the potential to treat multiple conditions, we view the
demonstration of safety as a fundamental step, which will position
the Company to expand use of this 'stem cell drug' for multiple
other indications," noted David Koos, the Company's Chairman &
CEO. "Having passed the clinical trial protocol approval and
the manufacturing approval, are major milestones for
Regen."
On May 9, 2014 the Company updated its IND with changes
requested by the FDA and submitted them for review.
About Regen BioPharma: Regen
BioPharma, Inc., a majority owned subsidiary of Bio-Matrix
Scientific Group, Inc. (PINKSHEETS: 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.
Currently the Company is focused on developing treatments for
Aplastic Anemia and a gene silencing therapy for treating cancer.
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