ROCKVILLE, Md., June 2, 2015 /PRNewswire/ -- RegeneRx
Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or
"RegeneRx") today announced a peer-reviewed publication of the
results of a recent cardiac stem cell clinical trial that
demonstrates the potentially key role that Thymosin beta 4 (TB4)
plays in the functional repair of cardiovascular disease. The
REGENERATIVE-IHD trial is the largest, randomized,
placebo-controlled clinical trial in the UK, to date, which was
designed to investigate the use of autologous bone marrow-derived
stem cells to improve cardiac function and symptoms in heart
failure patients. As part of the trial, the authors studied a
cohort of patients to determine if TB4 levels were affected by
injection of stem cells and whether this had a correlation with
clinical improvement. Serial plasma TB4 levels were obtained from
patients and concentrations were measured in those who received
stem cells and those who did not. According to the authors,
"There was a significant increase in circulating levels of TB4 [in
the stem cell-injected responder group only] 24 hours after
intracardiac injection, which was directly associated with
improvement in cardiac symptoms 6 months post-treatment."
"This is a very important study as it provides the first human
evidence documenting an important role for TB4 in improving heart
function in patients with ischemic heart failure, which has
previously only been seen in animal models, and the potential role
TB4 may play as an essential factor in mediating
cardiovascular repair," according to Dr. Allan L. Goldstein, Professor Emeritus of
Biochemistry and Molecular Medicine at The George Washington University and RegeneRx's
Chairman and Chief Scientific Advisor.
The study was conducted by Dr. F.A.
Choudry and his colleagues in the Department of Cardiology,
London Chest Hospital, Barts Health Trust; the British Heart
Foundation Laboratories, Department of Medicine, University College
and Centre for Clinical Pharmacology, Cardiovascular Biomedical
Research Unit; and The William Harvey Research Institute, Queen
Mary University, all located in London, UK. The research paper is
published in the current edition of Regenerative Medicine
(2015) 10(4), 403–410.
About RegeneRx Biopharmaceuticals, Inc.
(www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic
peptide, Thymosin beta 4, for tissue and organ protection, repair
and regeneration. RegeneRx currently has three drug candidates in
clinical development for ophthalmic, cardiac and dermal
indications, three active strategic licensing agreements in
China, Pan Asia (Korea,
Japan, and Australia, among others) and the U.S., and has
an extensive worldwide patent portfolio covering its products.
RGN-259, the Company's TB4-based ophthalmic drug candidate,
has been designated an orphan drug for the treatment of
neurotrophic keratopathy (NK). RegeneRx was recently allowed
by the FDA to move into Phase III clinical trials with RGN-259 for
the treatment of patients with NK. The drug candidate is also
being studied in patients with dry eye syndrome in the U.S. and
Asia. RegeneRx, through its U.S. joint venture, ReGenTree
LLC, is developing RGN-259 in the United
States and expects to initiate a Phase IIb/III trial later
this year. RGN-352, the Company's TB4-based injectable, is a Phase
2-ready drug candidate designed to be administered systemically to
prevent and restore tissue damage associated with acute events such
as heart attacks, strokes, and other similar traumatic
injuries. For additional information about RegeneRx please
visit www.regenerx.com.
Forward-Looking Statements
Any statements in this press release that are not historical
facts are forward-looking statements made under the provisions of
the Private Securities Litigation Reform Act of 1995. Any
forward-looking statements involve risks and uncertainties that
could cause actual results to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. There can be no assurance
that positive results from any clinical trials or research by the
Company, its collaborators, or independent parties in the U.S. or
any other country will result in subsequent clinical confirmation
or future value. There can also be no assurance that any of
the Company's drug candidates will result in any approved products
in the U.S. or any other country. Please view these and other
risks described in the Company's filings with the Securities and
Exchange Commission ("SEC"), including those identified in the
"Risk Factors" section of the annual report on Form 10-K for the
year ended December 31, 2014, and
subsequent quarterly reports filed on Form 10-Q, as well as other
filings it makes with the SEC. Any forward-looking statements in
this press release represent the Company's views only as of the
date of this release and should not be relied upon as representing
its views as of any subsequent date. The Company specifically
disclaims any obligation to update this information, as a result of
future events or otherwise, except as required by applicable
law.
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SOURCE RegeneRx Biopharmaceuticals, Inc.
