RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the
Company” or “RegeneRx”) has hired investment bankers, Ameritech
Advisors, LLC and Aurora Capital, LLC, to help the Company evaluate and
explore potential strategic opportunities. Additionally, the Company is
continuing to move forward in early-stage discussions with potential
strategic partners related to its ophthalmic drug candidate, RGN-259 for
the treatment of dry eye, which it had previously announced. During the
past few weeks, a number of additional companies have expressed interest
in exploring a partnering transaction involving RGN-259 or a broader
strategic transaction, and the Company is exploring these opportunities
as well.
About RegeneRx Biopharmaceuticals, Inc.
(www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide,
Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and
regeneration. RegeneRx currently has three drug candidates in clinical
development and has an extensive worldwide patent portfolio covering its
products.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic
indications. Based on a recently completed Phase 2 clinical trial in
patients with dry eye syndrome, RGN-259 was found to show statistically
significant improvements in several signs and symptoms of dry eye, as
well as positive trends in other outcome measures. We believe the
positive results of this Phase 2 exploratory trial reflect RGN-259’s
reported mechanisms of action and provide RegeneRx with FDA-approvable
endpoints to be targeted in future clinical trials.
RGN-352 is an injectable formulation to treat cardiovascular and central
nervous system diseases, as well as other medical indications. RegeneRx
is initially targeting RGN-352 for the treatment of patients who have
suffered an acute myocardial infarction, or heart attack. Recent
pre-clinical efficacy data suggests that RGN-352 may also benefit
patients with multiple sclerosis, stroke and traumatic brain injury.
RegeneRx has successfully completed a Phase 1 clinical trial with
RGN-352 in which the drug candidate was found to be safe and
well-tolerated. In 2010, RegeneRx received a $3 million, three-year
development grant from the NIH to support the company's acute myocardial
infarction program.
RGN-137, a topical gel formulation, is currently being evaluated by
RegeneRx in a Phase 2 clinical trial for the treatment of the orphan
skin disease epidermolysis bullosa. Other potential uses for RGN-137
include the treatment of chronic dermal wounds and reduction of scar
tissue. RegeneRx previously received $675,000 in grants from the U.S.
FDA to support this clinical trial.
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. 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. Forward-looking
statements in this press release include statements concerning a
potential strategic transaction involving the Company, a potential
partnering transaction involving RGN-259 and other statements that
include the words “believe,” “continue,” ”may,” “potential” or the
negative of those words or other similar expressions. Factors that may
cause actual results to differ materially from any future results
expressed or implied by any forward-looking statements include risks
related to uncertainties inherent in our business, including, without
limitation the risk that third parties may be unwilling to engage in a
strategic transaction on terms that are acceptable to the Company and
its stockholders or at all, the risk that potential commercial partners
may be unwilling to enter into a strategic partnership with us involving
RGN-259 or terms acceptable to us or at all, the risk that the Company
may require additional financing in order to continue as a going concern
for a sufficient period of time to consummate a strategic transaction or
partnering transaction, the risk that our product candidates do not
demonstrate safety and/or efficacy in current clinical trials or future
non-clinical or clinical trials; risks related to our ability to obtain
financing to support our operations on commercially reasonable terms;
the progress, timing or success of our clinical trials; difficulties or
delays in development, testing, obtaining regulatory approval for
producing and marketing our product candidates; regulatory developments;
the size and growth potential of the markets for our product candidates
and our ability to serve those markets; the scope and validity of patent
protection for our product candidates; competition from other
pharmaceutical or biotechnology companies; 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, 2010, filed
with the SEC on March 31, 2011, and quarterly reports 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
anticipates that subsequent events and developments may cause its views
to change, and the Company specifically disclaims any obligation to
update this information, as a result of future events or otherwise,
except as required by applicable law.
