RegeneRx Biopharmaceuticals, Inc. (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 enrolment 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. Additional details regarding the phase 2 trial may be seen online at:
“We are pleased patient enrolment 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 US 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.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. RegeneRx has recently completed two animal studies showing RGN-259’s positive effects on dry eye symptoms and has positive human data indicating its ability to heal corneal ulcers. Based on these data, the Company is sponsoring a double-masked, placebo-controlled phase 2 clinical trial. Of seven previous patients with non-healing ocular surface defects who were treated with RGN-259, all had complete or substantial healing. Three additional patients with corneal defects, called punctate keratitis, reported reduction in eye inflammation and increased comfort. RegeneRx is currently also supporting a small physician-sponsored Phase 2 dry eye study with RGN-259.
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx has successfully completed a phase 1 clinical trial with RGN-352 in which the drug candidate was found to be safe and well-tolerated over a wide dose range. The company previously planned to initiate a Phase 2 clinical trial at approximately 20 clinical sites in the US, Israel, and Russia; however, this trial is currently on an FDA-imposed clinical hold due to cGMP issues at an outside contract manufacturer. Last year, RegeneRx received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.
RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a phase 2 clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue.
Dry eye syndrome (DES) is a common disorder affecting a significant percentage of the population, especially those older than 40 years of age. It estimate that the number of people affected ranges from 25-30 million in the United States. Worldwide, the incidence rate is similar to that of the United States. According to Global Data, an industry market research firm, the world-wide annual market for dry eye disorders was approximately $1.9 billion in 2010 and is estimated to reach $2.8 billion by 2017.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair and regeneration.