ROCKVILLE, Md., May 8, 2015 /PRNewswire/ -- RegeneRx
Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug
development company focused on tissue protection, repair and
regeneration, today announced that independent researchers have
reported that diabetic mice treated long-term with Thymosin B4
(TB4) have significantly improved motor and sensory function in the
sciatic nerve compared to the untreated animals and that TB4
protects the nerves and reverses neurological damage in diabetic
neuropathy.
The improvement is closely associated with amelioration of
sciatic nerve axonal and myelin damage and an increase of
intraepidermal nerve fiber density. In vitro,
TB4-treated neurons derived from the diabetic mice had more
extensive neurite outgrowth compared to the untreated
neurons. Furthermore, the researchers identified the protein
that contributes to axonal remodeling.
"These results demonstrate the positive effects that TB4 has on
a well-accepted animal model of diabetic peripheral neuropathy and
again confirms the ability of TB4 to repair damage and promote
tissue regeneration in vivo. The positive
impact of TB4 on the tissue and nerve damage, as well as on the
function of the sciatic nerve, is extremely encouraging and
suggests a potential role for TB4 in the treatment of diabetic
peripheral neuropathy in humans. Moreover, the demonstration
that reduction of glucose was not required to see the effects of
TB4 is consistent with knowledge that reducing glucose levels does
not ameliorate diabetic peripheral neuropathy. In addition,
these new data are consistent with prior robust findings that TB4
has potent neurovascular restorative effects for both neural injury
and degeneration in the central and peripheral nervous systems,"
stated Michael Chopp, Ph.D., a
member of the research team, Scientific Director of the Henry Ford
Neuroscience Institute, and the Zoltan J. Kovacs Chair in
Neuroscience Research.
"Since progressive loss of peripheral nerve function due to
decreased nerve fibers and reduction in myelin is a major cause of
morbidity in diabetes and in other conditions, these findings on
the protective and restorative role of TB4 offer a significant
potential new therapy for these patients. This study is very
significant for RegeneRx as diabetic peripheral neuropathy is one
of the targets for the use of RGN-352, our injectable TB4
formulation developed for systemic administration, and supports our
continued investment in this area," stated J.J. Finkelstein, RegeneRx's president and chief
executive officer.
The research was conducted by Dr. Lei Wang and her colleagues in
the Department of Neurology at Henry Ford Hospital in Detroit, Michigan and the Department of
Physics at Oakland University in
Rochester, Michigan under a
Material Transfer Agreement between Henry Ford Hospital and
RegeneRx Biopharmaceuticals, Inc. The study was published in the
Journal of Diabetes Research; 2015:173656. Doi:
10.1155/2015/173656, Epub 2015 Apr
7.
About Diabetic Peripheral Neuropathy
Diabetes affects an estimated 346 million people worldwide.
Peripheral neuropathy is a progressive complication of diabetes and
is associated with degeneration and demyelination of peripheral
nerves. There is currently no effective treatment for
preventing the development or reversing the progression of diabetic
neuropathy. Symptoms can range from pain and numbness in the
extremities to problems with the digestive system, urinary tract,
blood vessels and heart and can be painful, disabling, and even
fatal.
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 in the U.S.
RGN-259, the Company's TB4-based ophthalmic drug candidate is being
developed for dry eye syndrome and for the treatment of
neurotrophic keratopathy (NK), both of which are being developed in
the U.S through its joint venture, ReGenTree. RGN-259 has
been granted orphan status by the U.S. FDA and was recently allowed
by the FDA to move into phase 3 clinical trials for the treatment
of patients with NK. RGN-352, the Company's TB4-based
injectable drug candidate, 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 injuries. RGN-137, the Company's
TB4-based dermal gel, is in phase 2 clinical development. 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 any research published by the Company or any third party will
be able to be replicated in human conditions, disorders or
injuries, or prove to be commercially valuable. 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.
