ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced positive data from its 72-patient, Phase 2 clinical trial with RGN-259, a sterile, preservative-free eye drop, to evaluate its safety and efficacy for the treatment of signs and symptoms of dry eye syndrome over a treatment period of 30 days using the Controlled Adverse Environment (CAE) model. The trial was conducted by ORA Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials. The first-in-class drug candidate was deemed safe and well-tolerated and showed efficacy in a number of key CAE-related parameters.
After challenge in a controlled adverse environment, RGN-259 showed statistically significant results in:
- Reduction from baseline in central corneal fluorescein staining compared to placebo at the 24 hour recovery period (p = 0.0075). Reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the central cornea;
- Reduction from baseline in exacerbation of superior corneal fluorescein staining in the chamber as compared to the placebo (p = 0.0210); and
- Reduced exacerbation of ocular discomfort at day 28 during a 75-minute challenge in a controlled adverse environment compared to the placebo group (p = 0.0244). Reduction indicates that RGN-259 can slow exacerbation of ocular symptoms in patients with dry eye syndrome.
While the study did not meet the two primary outcome measures selected prior to the beginning of the trial, statistically significant sign and symptom improvements attributable to RGN-259 were identified. We believe these sign and symptom improvements are clinically relevant endpoints that would be acceptable outcome measures for future pivotal trials, which we intend to confirm with FDA at a post-Phase 2 meeting.
“We believe these data are very encouraging. This trial has allowed us to identify specific dry eye signs and symptoms that could be targeted as primary outcome measures in future clinical trials,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer. “Along with other positive findings, reduction of exacerbation of corneal staining and ocular discomfort during CAE exposure correlate well with RGN-259’s reported mechanisms of action.”
“The Thymosin beta 4 activity of RGN-259 offers an exciting novel mechanism of action for treatment of dry eye syndrome, having anti-inflammatory, anti-apoptotic, and wound healing properties. Along with the evaluation of safety, this Phase 2 exploratory clinical trial was designed to evaluate the effect of RGN-259 on numerous signs and symptoms of dry eye. The positive results around the challenge-related endpoints are meaningful and warrant further investigation of RGN-259,” stated George Ousler, Ora’s vice president of dry eye.
About Dry Eye Syndrome
Dry eye syndrome is a common disorder affecting a significant percentage of the population, especially those older than 40 years of age, including an estimated 25-30 million in the U.S. Worldwide, the incidence is similar to that of the U.S. According to Global Data, an industry market research firm, the worldwide 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. (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 product candidates.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. RegeneRx has recently completed two animal studies in Ora’s murine CAE model showing RGN-259’s positive effects on dry eye signs and has positive human data indicating its ability to heal corneal ulcers. Based on these data, the Company is sponsoring a Phase 2 clinical trial described in this release. RegeneRx is also supporting a second, physician-sponsored Phase 2 dry eye study with RGN-259.
RGN-352 is an injectable formulation of Tβ4 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 over a wide dose range. The Company previously planned to initiate a Phase 2 clinical that is currently on an FDA-imposed 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 of Tβ4, 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.
About Ora Inc. (www.oraclinical.com)
Ora is the world’s leading independent ophthalmic development firm with 32 FDA approvals during its 30 year history. Ora helps companies, from start-ups to global pharmaceutical companies, efficiently and successfully bring their new ophthalmic products from concept to market. Ora’s clinical models and unique methodologies have been refined across thousands of development projects. These models and methods consistently generate accurate and reliable data to support regulatory approvals, both in the US and around the world.
Ora provides a complete range of development services, including preclinical models, CMC, clinical research, regulatory strategy, statistics and data management, medical writing, and marketing and advertising services. Ora also brings together the world’s most extensive and experienced network of ophthalmic experts, clinical investigators, investment partners, and industry-leading companies in order to enable clients to maximize the value of their new product initiatives.
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 “believe,” “could,” “future,” “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 future 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 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.