Positive data from RegeneRx RGN-259 Phase 2 trial on dry eye syndrome

Nov 5 2011

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.

Source: RegeneRx Biopharmaceuticals, Inc.