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Celsus Therapeutics Plc Receives Approval From the Ministry of Health of Israel for Phase II Trial of MRX-6 in Pediatric Atopic Dermatitis Patients

Globe Newswire

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 ( 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.

FORWARD-LOOKING STATEMENTS – This press release contains "forward-looking statements" that involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," "hope," "look forward" and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 20-F discusses some of the important risk factors that may affect our business, results of operations and financial condition. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.

CONTACT: Investor Relations Contact The Trout Group Tricia Truehart 646-378-2953 Media Contact: Dian Griesel Int'l. Susan Forman 212-825-3210Source:Celsus Therapeutics