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Celsus Therapeutics Announces FDA Allowance of IND for Clinical Development of MRX-6 Cream in Atopic Dermatitis

NEW YORK and LONDON, Jan. 12, 2015 (GLOBE NEWSWIRE) -- Celsus Therapeutics (Nasdaq:CLTX), an emerging growth, development-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug Application (IND) for the clinical development of MRX-6 Cream 2% in patients with atopic dermatitis. The FDA's allowance of the IND permits the Company to expand its clinical program in atopic dermatitis to the United States. The Company plans to initiate enrollment of a Phase II double blind, vehicle controlled, dose ranging trial of MRX-6 cream testing 0.1%, 1% and 2% vs vehicle in the first quarter of 2015.

"We are very excited to expand our Phase II program into the United States," said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "Along with the positive results from our earlier clinical trials in allergic contact dermatitis, and our ongoing trial in pediatric atopic dermatitis, this trial will help us better understand the effect of MRX-6 in skin inflammation and prepare us for our U.S. Phase III clinical program, which we expect to begin in late 2016. 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."

The upcoming Phase II trial will test three doses (0.1%, 1% and 2%) versus vehicle to evaluate the safety and efficacy of MRX-6 cream in a population with mild to moderate atopic dermatitis. The trial will enroll 168 patients into a four-week double-blind period. Results from this trial are expected in the first quarter of 2016.

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 inflammatory 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 atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and OAX-1 for osteoarthritis.

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 ttruehart@troutgroup.com 646-378-2953Source:Celsus Therapeutics