Celsus Therapeutics Announces Positive Phase II Interim Results for MRX-6 in the Treatment of Contact Dermatitis
May 8 13
Celsus Therapeutics announced positive interim results from the first cohort (2% MRX-6 vs. vehicle) of a multi-center Phase II double blind, two step dose-ranging, vehicle and active control study of MRX-6 for the treatment of patients with allergic contact dermatitis (ACD). MRX-6 is a multi-functional non-steroidal anti-inflammatory cream working through the inhibition of sPLA2, a steroid target, and through enriching cell surface glycosaminoglycans (GAG). Data released are for treatment with the highest (2.0%) dose of MRX-6 and vehicle control. The results show a 56% improvement in symptoms (dryness, scaling, redness, pruritus and fissures) from baseline in the MRX-6 treated hand/forearm, compared to a 24% improvement for vehicle ('placebo') treated hand/forearm (p < 0.0001). Each patient acted as his or her own control. Clinically significant benefit, defined as greater than or equal to 50% reduction in symptoms from baseline in the MRX-6 treated hand/forearm, was seen in 70% of patients. MRX-6 was found to be safe and well-tolerated, with no adverse events. The benefit was similar regardless of patient baseline score, study center or symptom sub-score. This Phase II, double-blind, two-part dose ranging and active control study plans to enroll 85 patients with moderate to severe ACD, as determined by the Physician Visual Assessment Score (PVA). Patients recruited to the study displayed similar disease severity on both hands as determined by the PVA, which scores five items (dryness, redness, scaling, pruritus and fissures) each on a scale of 0-3 (none, mild, moderate or severe) for a total symptom score of 0-15. Patients receive the vehicle cream ('placebo') on one hand and the active drug to be used only on the other (i.e., each patient acted as his/her own control) twice a day for 21 days. The study is being conducted in two parts; part one (just unblinded) enrolled 30 patients at the highest, 2% concentration, of MRX-6. In the next part of the study, to be carried out in the second half of 2013, 55 patients will again act as their own controls but will receive in a random manner either MRX-6 (1%, 0.2%) or topical steroids, for 21 days. The primary efficacy outcome is defined as the difference in percentage change from baseline to day 21 in the PVA score for the treated versus vehicle hand/forearm. The secondary outcomes include the evaluation of the safety and tolerability of the three doses of MRX-6 and efficacy by symptom sub-score.
Celsus Therapeutics Appoints Robert F. Doman to the Company's Board of Directors
May 1 13
Celsus Therapeutics announced the addition of industry veteran Robert F. Doman to the Company's Board of Directors. Mr. Doman is a seasoned pharmaceutical and medical device executive with 30+ years of extensive international and domestic experience in general management, business development, building sales and marketing capabilities, new product development and strategic planning. Most recently Bob served as President and Chief Executive Officer of DUSA Pharmaceuticals Inc.
Morria Biopharmaceuticals Plc Appoints Fredric Price as Board of Director
Apr 30 13
Morria Biopharmaceuticals Plc announced that Fredric Price has joined the company's board of directors. Mr. Price is Executive Chairman of the Board of Directors of Chiasma, having served as its Chairman and CEO from 2008 to 2013, stepping down as CEO in March 2013 after completing a strategic collaboration for its Phase 3 oral drug candidate in acromegaly with Roche. Previously, he was Executive Chairman of the Board of Directors
of Omrix Biopharmaceuticals (2004-2008) a member of the Board of Directors of Enobia Pharma (2006-2012), a member of the Board of Directors of Pharmasset (2007-2010), Executive Chairman of the Board of Directors of Peptimmune (2007-2011), Chairman of the Board of Directors and CEO of BioMarin Pharmaceutical (2000-2004) and CEO and a member of the Board of Directors of Applied Microbiology (1994-2000).