Celsus Therapeutics Receives Ministry of Health of Israel Approval to Conduct Phase II Trial of MRX-6 in Pediatric Atopic Dermatitis Patients

06/17/2014

Celsus Therapeutics Plc received approval from Ministry of Health of Israel for Phase II Trial of MRX-6 in Pediatric Atopic Dermatitis Patients.

The Company plans to conduct the study in five to six centers in Israel as well as Argentina. They plan to enroll 80 pediatric patients ranging from two to 17 years. The trial is a double-blind, parallel-group, vehicle-controlled study designed to evaluate the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis. Patients will be enrolled in a four-week double-blind period, followed by a four-week open label extension for those patients who wish to continue in the trial. Results from this trial are expected in the fourth quarter of 2014.

Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics said, "Along with the positive results from our earlier trials in allergic contact dermatitis, this trial will help us better understand the effect of MRX-6 in skin inflammation and prepare us for our U.S. Phase II clinical program, which we expect to begin in early 2015. We believe MRX-6 will provide a safe and effective alternative to topical steroids and calcineurin inhibitors for children and adults suffering from atopic dermatitis."

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