NEW YORK and LONDON, June 17, 2014 (GLOBE NEWSWIRE) -- Celsus Therapeutics Plc (Nasdaq: CLTX ), an emerging growth, development-stage biotech company, has received approval from the Israeli Ministry of Health to conduct a Phase II trial of MRX-6 cream 2% in pediatric patients with atopic dermatitis.
The Company plans to conduct the study in five to six centers in Israel as well as Argentina, enrolling 80 pediatric patients ranging in age from two to 17 years. The trial is a double-blind, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis ( Clinicaltrials.gov NCT02031445 ). The trial will enroll patients into 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.
"We are very excited to initiate this study and recruit patients," said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "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."
About Celsus Therapeutics Plc
Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus's MFAIDs represent a new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as allergies and autoimmune diseases. Presently, the Company's lead drug candidate in its clinical pipeline is MRX-6, an MFAID topical cream treatment under development for treating skin inflammatory disorders, specifically allergic contact dermatitis and atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and MRX-5 for inflammatory bowel disease.
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Investor Relations Contact The Trout Group Tricia Truehart 646-378-2953 Media Contact: Dian Griesel Int'l. Susan Forman 212-825-3210
