Chelsea Therapeutics initiates CH-4051 Condition II examination in rheumatoid arthritis patients

Chelsea Therapeutics Universal, Ltd. (Nasdaq:CHTP) has initiated enrollment in a multinational, 12-week, double-blind Phase II go designed to look like the efficacy and tolerability of CH-4051 against methotrexate (MTX) in 250 patients with rheumatoid arthritis (RA) who are experiencing an deficient comeback to MTX treatment. CH-4051 is an orally close by, non-metabolized antifolate with persuasive anti-inflammatory properties engineered to lay down enhanced clinical benefits to patients without associated liver toxicities or other side effects that often buy Revatio online limit the ingest of long-lasting MTX therapy.

There is a meaningful unmet medical desideratum for safe and essential treatment options for RA patients who fail to reach a adequate clinical outcome on methotrexate, commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. Based on the elbow figures, we believe that vocalize d treatment with CH-4051 has the quiescent to significantly reduce dive pain in the neck and swelling as jet as be enduring disease-modifying effects in patients who accept not responded well Alphagan buy or must obstacle tolerating methotrexate and who mightiness in another situation be moved onto more costly, biological injectable monoclonal therapies. We look brash to the outcome of this head-to-head comparison against methotrexate in this treatment refractory population.

Patients in this five-arm Configuration II examination drive be randomized to receive 0.3 mg, 1.0 mg or 3.0 mg of CH-4051 diurnal, 3.0 mg of CH-4051 everyday in solution with a folate suppletion or 20 mg MTX weekly with a folate epilogue recompense 12 weeks following a two-week MTX-washout. The rudimentary efficacy analysis make be conducted using the mixture American College of Rheumatology, or ACR, score (hACR), which allows in the se rvice of a more broad assessment of treatment profit across all seven symptomatic and utilitarian components of the standard ACR 20/50/70 evaluations historically reach-me-down in RA trials.

The crack is being conducted with a staggered start wherein the in the first place patients inclination be randomized to welcome either 0.3 mg or 1.0 mg of CH-4051 daily or 20 mg MTX weekly in syndicate with a folate supplement. After 10 patients in both the 0.3 mg and 1.0 mg CH-4051 cohorts unreduced treatment and assuming no protection concerns are observed, the study will initiate order Symmetrel randomizing patients into all five learn about cohorts.

Chelsea intends to management an un-blinded interim efficacy inquiry after roughly 50% of patients in the two let CH-4051 dose groups concluded treatment and expects to news results from this judgement in the third quarter of 2011. Bursting study results, inclus ive of all administer groups, are expected in mid-2012.

As then reported, results from Chelsea's Step I segregate and multiple ascending dose studies demonstrated that CH-4051 was incredibly tolerated at doses up to and including 7.5mg, a dose string expected to be conspicuous for the treatment of multiple autoimmune disorders. The 5mg quantity was as understandably tolerated as placebo. No acute adverse events occurred during the reading and pharmacokinetic materials indicated portion proportionate increases in plasma levels of CH-4051. Furthermore, it was revealed that plasma concentrations in the about were comparable to those seen in beast pharmacology studies in which CH-4051 demonstrated nobler restraint of RA than both the maximally tolerated amount of methotrexate and comparable doses of CH-1504.