RegeneRx
RegeneRx Set to Begin Enrolling Phase 2 Dry Eye TrialFirst Patients Expected to Begin Treatment on August 13thJuly 28, 2011 — Rockville, Md.
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye
syndrome. The Company anticipates enrollment of the first patients on August 13th, and expects preliminary data
from the study to be available in October 2011. The trial is a double-masked, placebo-controlled trial testing the
safety and efficacy of RGN-259, the Company’s proprietary preservative-free eye drops, against a placebo.
Patients will receive RGN-259 or placebo twice daily for 30 days. Signs and symptoms of dry eye, such as the
degree of ocular surface damage, ocular itching, burning and inflammation, among others, will be measured
periodically during the treatment period. The trial will be conducted by ORA Inc., an ophthalmic contract
research organization that specializes in dry eye research and clinical trials. Additional details regarding the
Phase 2 trial may be seen online at:
- http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin+beta+4&rank=5
“We have received Institutional Review Board approval for the trial, completed manufacturing of RGN-259 and
placebo, and are currently preparing for enrollment of the first patients,” stated J.J. Finkelstein, RegeneRx’s
president and chief executive officer. “This is a very important clinical trial for RegeneRx that is based on a body
of human and preclinical data that suggest RGN-259 could have beneficial effects in treating dry eye. Everyone
at RegeneRx, as well as those associated with the project, are encouraged about the prospects for RGN-259 to
improve the signs and symptoms associated with dry eye syndrome, a condition with limited treatment options.”
RGN-259 has been shown to reduce corneal damage associated with dry eye syndrome in two animal models
when compared to both positive and negative controls. In one experiment, RGN-259 was also shown to reduce
such damage better than Restasis™, the only drug currently approved by the FDA to treat dry eye syndrome. In
several comparisons to controls, the improvements with RGN-259 were statistically significant. These data were
presented at the 2011 ARVO meeting this past spring.
Human data have been published indicating that RGN-259 can successfully heal ocular surface defects, which
often occur as a result of dry eye syndrome. The first patient ever treated with RGN-259, who had a non-healing
corneal wound 23 days after surgery, healed within 11 days after treatment with RGN-259. In a series of six
patients with neurotrophic keratitis, all of whom had eye ulcers that had not healed for a minimum of six weeks,
all either completely healed or substantially healed within the treatment period.
About Dry Eye Syndrome
Dry eye syndrome (DES) is a common disorder affecting a significant percentage of the population, especially
those older than 40 years of age. It estimate that the number of people affected ranges from 25-30 million in the
United States. Worldwide, the incidence rate is similar to that of the United States. According to Global Data, an
industry market research firm, the world-wide annual market for dry eye disorders was approximately $1.9 billion
in 2010 and is estimated to reach $2.8 billion by 2017. The development of dry eyes can have many causes. They
include: (1) age – people over age 65 often experience some symptoms of dry eyes; (2) gender – women are more
likely to develop dry eyes due to hormonal changes caused by pregnancy, the use of oral contraceptives, and
menopause; (3) medications – certain medicines, including antihistamines, decongestants, blood pressure
medications and antidepressants; (4) medical conditions – persons with rheumatoid arthritis, diabetes, thyroid
problems, Sjögren’s syndrome, and lupus are more likely to have symptoms of dry eyes; (5) blepharitis –
inflammation of the surfaces of the eye, or the inward or outward turning of eyelids can cause dry eyes to
develop; (6) environmental conditions – exposure to smoke, wind and dry climates can increase tear evaporation
resulting in dry eye symptoms; (7) other factors – long term use of contact lenses, and refractive eye surgeries,
such as LASIK.
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 product candidates.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. RegeneRx has recently
completed two animal studies showing RGN-259’s positive effects on dry eye symptoms and has positive human
data indicating its ability to heal corneal ulcers. Based on these data, the Company is sponsoring a doublemasked,
placebo-controlled Phase 2 clinical trial. Of seven previous patients with non-healing ocular surface
defects who were treated with RGN-259, all had complete or substantial healing. 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. RegeneRx is currently also supporting a small physician-sponsored Phase 2
dry eye study with RGN-259.
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other
medical indications. 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 previously initiated a Phase 2 clinical trial
at approximately 20 clinical sites in the U.S., Israel, and Russia, although this trial is currently on an FDAimposed
clinical hold due to cGMP issues at an outside contract manufacturer. Last year, 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.
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. These 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 “expect,” “estimate,” “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 risks related to uncertainties
inherent in our business, including, without limitation the risk that our product candidates do not demonstrate
safety and/or efficacy in 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
subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forwardlooking
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.