ROCKVILLE, Md., May 22, 2015 /PRNewswire/ -- RegeneRx
Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or
"RegeneRx") today announced a peer-reviewed publication of the
results of the Company's 72-patient, placebo-controlled Phase II
study evaluating RGN-259 (RegeneRx's preservative-free eye drops)
for the treatment of dry eye patients using Ora Inc.'s controlled
adverse environment (CAE®) model. The exploratory
study was completed in late 2011, and the results, which were
previously disseminated by the Company in a press release, identify
the key efficacy targets for a larger, multi-center, Phase IIb/III
U.S. clinical trial targeted for later this year. The trial
will be sponsored by ReGenTree, LLC, a U.S. joint venture owned by
RegeneRx and G-treeBNT.
In this just published study, a number of important outcome
measures, including central, superior, and peripheral corneal
staining demonstrated statistically significant improvements in the
RGN-259-treated group compared to placebo (p=0.0075, p=0.0210 and
p=0.0379, respectively). RGN-259 also reduced exacerbation of
ocular discomfort after CAE® challenge (p=0.0224).
The drug candidate was well-tolerated and there were no observed
adverse side effects. As previously reported, the co-primary
outcome measures, inferior corneal staining and patient ocular
discomfort 24 hours after CAE® challenge, did not show
statistically significant differences.
"We are quite excited to have identified significant
improvements in both signs and symptoms of dry eye, which have
since been confirmed in subsequent studies. Not only have we
identified FDA-approvable sign and symptom endpoints that will be
the target of U.S. dry eye trials later this year, we also saw the
potential for RGN-259 as a preventative modality for patients prone
to dry eye syndrome as evidenced by their improvements after
challenge in a controlled adverse environment. Additionally,
the statistically significant improvements in central corneal
staining at 24 hours post-CAE® are consistent with the
acceleration of healing seen in other patients treated with
RGN-259. We look forward to the larger, more robust study
that is expected to begin later this year," stated Dr. Gabriel Sosne, Associate Professor, Department
of Ophthalmology and Anatomy/Cell Biology, Wayne State University School of Medicine Kresge
Eye Institute, Detroit, Michigan,
and one of the authors of the paper. Dr. Sosne is a member of
RegeneRx's Scientific Advisory Board.
The clinical trial report, "Thymosin beta 4 ophthalmic solution
for dry eye: a randomized, placebo-controlled, Phase II clinical
trial conducted using the controlled adverse environment (CAE™)
model," was authored by Gabriel
Sosne and George Ousler and
published in Clinical Ophthalmology, May 2015; Vol. 2015:9, 877-884.
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.
About Ora Inc.
Ora Inc. is a global, full-service ophthalmic clinical research
and product development firm. Over the past 30 years, it has helped
clients earn 39 FDA approvals. Ora supports a wide array of
organizations, from start-ups to global pharmaceutical and device
companies, to efficiently and successfully bring their new products
from concept to market. Ora's pre-clinical and clinical models,
unique methodologies and regulatory strategies have been refined
and proven across thousands of projects both in the U.S. and
internationally. Ora brings together the world's most extensive and
experienced network of ophthalmic experts and R&D professionals
in order to maximize the value of new product initiatives.
For additional information, please visit
http://oraclinical.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 by the Company, or
its collaborators, 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.
