Date: 2014-08-06
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Celsus Therapeutics (UK - USA)
Product: MRX-6
Action
mechanism: 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.
Disease: atopic dermatitis
Therapeutic area: Dermatological diseases - Immunological diseases - Inflammatory diseases
Country: Argentina, Israel
Trial
details: 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).
Latest
news: * On August 6, 2014, Celsus Therapeutics announced the first patient has been enrolled in its 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 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. * On June 17, 2014, Celsus Therapeutics 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 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. The company expects to begin an U.S. Phase II clinical program in early 2015. * On March 11, 2014, Celsus Therapeutics announced that it held a pre-Investigational New Drug (pre-IND) meeting with the FDA on February 12th, 2014, to discuss the regulatory pathway for the development of MRX-6 cream in atopic dermatitis. 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.
