RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

Jul 29 2011

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 13^th, 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.

"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.

Source: RegeneRx Biopharmaceuticals, Inc.