First Patient Screened in Phase 2 Trial with RegeneRx’s RGN-259 for Dry Eye Syndrome
December 22 2010 - 9:16AM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex: RGN) (“the
Company” or “RegeneRx”) announced today that the first patient has
been screened and is being enrolled in a Phase 2 clinical trial
testing the Company’s drug candidate RGN-259 in patients with dry
eye associated with graft vs. host disease. The double-blind,
placebo-controlled, investigator-sponsored trial is expected to
enroll a total of 20 patients over the next several months, with
data reported later in 2011. RGN-259 is a sterile,
preservative-free topical eye drop formulation of the novel
therapeutic peptide Thymosin beta 4, or Tβ4.
The clinical trial is being conducted under a
physician-sponsored IND in Detroit, Michigan. Steven Dunn, M.D.,
the principal investigator in this study, is an ophthalmologist and
corneal specialist who previously treated a group of patients with
recalcitrant neurotrophic keratitis with RGN-259. In a group of six
such patients, Dr. Dunn reported substantial healing within the
treatment period or follow-up. His results have been published in
the Archives of Ophthalmology and the
Annals of the New York Academy of
Sciences. Gabriel Sosne, M.D., Associate Professor of
Ophthalmology at Wayne State University School of Medicine, a
member of RegeneRx’s Scientific Advisory Board, has spent a number
of years conducting research with Tβ4 and is an investigator in the
trial.
“The first patient is an important milestone in the use of
RGN-259 for the treatment of dry eye. Drs. Dunn and Sosne have
played critical roles in developing RGN-259 for a number of
potentially significant ophthalmic indications, and we are
optimistic that their work in this study will continue the
significant progress seen over the past few years. A successful
Phase 2 dry eye trial, in addition to the positive dry eye animal
study announced early last month, would be strong evidence of
RGN-259’s capabilities for the treatment of dry eye and other
ophthalmic conditions,” stated J.J. Finkelstein, president and CEO
of RegeneRx Biopharmaceuticals.
Dry Eye Syndrome
Dry Eye Syndrome, or DES, is a common condition that affects up
to 10% of the U.S. population between the ages of 30 and 45,
increasing up to 20% of people age 45 and above. The typical
clinical manifestations of DES include ocular irritation, blurring
and fluctuating vision, and DES carries an increased risk of
sight-threatening corneal infections and ulcerations. Currently
available dry eye treatments typically provide only temporary
relief of symptoms.
About RegeneRx Biopharmaceuticals, Inc.
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-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 preclinical 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.
The company has initiated a Phase 2 clinical trial and expects to
enroll the first patient by early 2011 at approximately 25 clinical
sites in the U.S., Israel, and Russia. RegeneRx is also supporting
a Phase 1/2 physician-sponsored clinical trial in patients with
multiple sclerosis that is expected to begin in 2011. RegeneRx
recently received a $3 million, three-year development grant from
the NIH to support the company’s acute myocardial infarction
program.
RGN-259 is a sterile, preservative-free topical eye drop for
ophthalmic indications. Based on recent human clinical data,
RegeneRx is currently supporting a physician-sponsored Phase 2 dry
eye study with RGN-259. Previously, seven patients with non-healing
corneal ulcers were treated with RGN-259 under compassionate use
INDs. Five had complete healing and two had substantial healing of
their wounds. Three additional patients with corneal defects,
called punctate keratitis, had no evidence of healing although they
did report reduction in eye inflammation and increased comfort.
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.
In addition to the pharmaceutical product candidates described
above, RegeneRx is pursuing the commercial development of peptide
fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds
numerous patents and patent applications worldwide related to its
products, and holds an exclusive worldwide license from the
National Institutes of Health, as well as other licenses related to
Tβ4. The Company recently received $733,438 in funding under the
Patient Protection and Affordable Care Act to support each of its
product candidates.
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. You are urged to consider
statements that include the words “believe,” “plan,” “expect,”
“intend,” “could,” “will,” ”may,” “potential” or the negative of
those words or other similar expressions to be uncertain and
forward-looking. Factors that may cause actual results to differ
materially from any future results expressed or implied by any
forward-looking statements include the risks and uncertainties
inherent in our business, including, without limitation the risk
that our product candidates do not demonstrate safety and/or
efficacy in the Phase 2 Dry Eye clinical trial, 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, 2009,
filed with the SEC on March 31, 2010, and the quarterly report on
Form 10-Q for the quarter ended September 30, 2010, 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.
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