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Catalyst Pharmaceutical Partners Inc Announces Recommendation Of Data Monitoring Committee For Pivotal Phase lll Clinical Trial For Firdapse


Wednesday, 27 Mar 2013 08:03am EDT 

Catalyst Pharmaceutical Partners Inc announced that on March 25, 2013, the independent Data Monitoring Committee (DMC) overseeing the Company's ongoing pivotal Phase III clinical trial in the United States and Europe evaluating Firdapse for the treatment of Lambert-Easton Myasthenic Syndrome (LEMS) recommended that the Company continue the trial as planned based on the committee's review of safety and clinical data from the trial. on March 25, 2013, the independent Data Monitoring Committee (DMC) overseeing the Company's ongoing pivotal Phase III clinical trial in the United States and Europe evaluating Firdapse for the treatment of Lambert-Easton Myasthenic Syndrome (LEMS) recommended that the Company continue the trial as planned based on the committee's review of safety and clinical data from the trial. The DMC considers study-specific data, as well as relevant background knowledge about the disease, test agent or patient population under study. The Firdapse Phase III clinical trial is designed as a randomized, double-blind, placebo-controlled, discontinuation trial enrolling 30 patients diagnosed with LEMS at sites in the U.S. and Europe. Catalyst anticipates that it will be adding up to 20 additional sites in the U.S., Europe, Canada and South America. Catalyst expects to complete enrollment in the trial by the end of the fourth quarter of 2013 and to announce top line data from the trial during the second quarter of 2014. 

Company Quote

2.3
-0.01 -0.43%
9 Jul 2014