NEW YORK and LONDON, Jan. 13, 2015 (GLOBE NEWSWIRE) -- Celsus Therapeutics (Nasdaq:CLTX), an emerging growth, development-stage biopharmaceutical company, announced today that the Company has completed enrollment of C012013, a Phase II, 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. The trial enrolled 73 children with mild to moderate atopic dermatitis 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. Topline data from the double blind portion of the trial are expected by end-February, 2015.
“The completion of enrollment of the C012013 Phase II trial represents an important milestone for both the company and the MRX-6 program,” said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. “This trial will provide important insight into the activity of MRX-6 in pediatric atopic dermatitis, and we are thankful for the deep interest and support demonstrated by the parents and children with atopic dermatitis who enrolled in our trial and by our investigators. 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 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 646-378-2953
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