Celsus Therapeutics Provides Update on MRX-6 From FDA Pre-IND Meeting

  • Celsus completes Type B pre-IND meeting with FDA for MRX-6 cream in atopic dermatitis
  • MRX-6 to advance into Phase II trials in US upon filing of IND expected in 4Q14

NEW YORK and LONDON, March 11, 2014 (GLOBE NEWSWIRE) -- Celsus Therapeutics Plc (Nasdaq:CLTX), an emerging growth, development-stage biotech company, announced today that it held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on February 12th, 2014, to discuss the regulatory pathway for the development of MRX-6 cream in atopic dermatitis, also known as eczema, an inflammatory skin disorder affecting 5% to 20% of children world-wide. The Company plans to file the IND for MRX-6 with the FDA in the fourth quarter of 2014, and initiate Phase II trials in the US in the first half of 2015.

"We appreciate the openness and guidance provided by the FDA in our discussion," said Dr. Pablo Jimenez, Chief Medical Officer of Celsus Therapeutics. "We plan to submit our IND for MRX-6 cream in atopic dermatitis during the fourth quarter of 2014 after we have completed our manufacturing and toxicology programs. With the filing of the IND, we will be able to advance into Phase II trials in the US in early 2015 and aim to begin our Phase III program in the first half of 2016."

"The ability to accelerate our MRX-6 program and advance into Phase II trials in the US following the IND will greatly advance the execution of our dermatology program in 2015," said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "We believe that MRX-6 will provide a safe and effective alternative to topical steroids and calcineurin inhibitors, and we will work closely with the FDA to develop a new therapy for children and adults suffering from atopic dermatitis."

About MRX-6 – Dermatitis

MRX-6 is a Multi-Functional Anti-Inflammatory Drug (MFAID) topical cream under development for treating skin inflammatory disorders, specifically allergic contact dermatitis and atopic dermatitis, also known as eczema. MFAID's are designed to inhibit extracellular secretory phospholipase A2 (sPLA2), a catalytic enzyme responsible for initiating the inflammatory cascade through the production of arachidonic acid from membrane in the US-associated phospholipids, specifically at the cell surface. MFAIDs can inhibit all sPLA2 isomers without disrupting cytoplasmic phospholipase A2 (cPLA2), a crucial homeostatic enzyme within cells. MFAIDs also enrich cell surface glycosaminoglycans, protecting cells from exposure to oxygen radicals and certain cytokines.

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