Phase II Dose Ranging Clinical Trial in Atopic Dermatitis Expected to Begin in First Quarter of 2015
NEW YORK, NY, USA and LONDON, UK I January 12, 2015 I Celsus Therapeutics (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.
SOURCE: Celsus Therapeutics
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Phase II Dose Ranging Clinical Trial in Atopic Dermatitis Expected to Begin in First Quarter of 2015
NEW YORK, NY, USA and LONDON, UK I January 12, 2015 I Celsus Therapeutics (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.
SOURCE: Celsus Therapeutics
Post Views: 83
