RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") has announced that the first patients have been enrolled and randomized to receive RGN-259 or placebo in its 72-patient, Phase 2 clinical trial in patients with dry eye syndrome. The Company expects to complete patient enrollment in August and for the last patient to complete the study the third week in September, with preliminary data from the study scheduled to be available in October 2011. The trial is a double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops. 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 grittiness, among others, will be 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 pleased patient enrollment has proceeded as scheduled and look forward to completing this important clinical trial and evaluating patient data as quickly as possible," stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.
RGN-259 has been shown to reduce ocular surface defects associated with dry eye syndrome in two animal models when compared to 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 improvements with RGN-259 were statistically significant. These data were presented at the 2011 ARVO meeting this past spring.
Human data have been reported and published indicating 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 after 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.
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