RegeneRx completes RGN-259 Phase 2 trial on dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") today announced that treatment and follow-up have been completed on 69 patients in the Company's Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial's protocol. After all study data completes the quality control process and data lock it will then undergo statistical analyses. The trial is on schedule for top-line results to be reported in late October.

This double-masked, placebo-controlled clinical trial will evaluate the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops, in patients with dry eye syndrome. Patients received 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 grittiness, among others, was graded periodically during and following the treatment period. The trial is being conducted by Ora Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials.

"We are very excited about the potential for development of RGN-259 to treat dry eye syndrome and are looking forward to reporting top-line data in the latter part of October," said J.J. Finkelstein, chief executive officer of RegeneRx. "Dry eye syndrome is an all-too-common disorder and current treatments are inadequate in a majority of cases. As such, should the data be positive, we believe a Phase 3 study could be initiated early next year, either by a strategic partner or RegeneRx, providing a relatively low-cost clinical development opportunity for a high-value indication."

In two animal models RGN-259 reduced ocular surface defects associated with dry eye syndrome compared with both positive and negative controls. In one experiment RGN-259 performed better than Restasis™ in reducing such damage. Restasis is the only drug currently approved by the U.S. Food and Drug Administration to treat dry eye syndrome. In several comparisons to controls, the clinical improvements with RGN-259 were statistically significant. These data were presented at the 2011 ARVO meeting this past spring.

Published human data indicate that RGN-259 can successfully heal ocular surface defects, which most often occur as a result of dry eye syndrome and particularly in patients with moderate-to-severe dry eye. The first patient ever treated with RGN-259, who had a non-healing corneal wound 23 days after surgery, healed within 11 days during treatment with RGN-259. In a series of six patients with neurotrophic corneal epithelial defects that had not healed for a minimum of six weeks, all either completely healed or substantially healed within the treatment period.