Dry eye drugs: Regenerx RGN259 completed Phase II

Results expected late October.

More details in news report.

ROCKVILLE, Md., Sep 23, 2011 (BUSINESS WIRE) -- RegeneRx Biopharmaceuticals, Inc. RGRX -3.13% ("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. Additional details regarding the Phase 2 trial are available at:

http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin +beta+4&rank=5