Catalyst Pharmaceutical
Partners, Inc. CPRX, a specialty pharmaceutical company focused on
the development and commercialization of novel prescription drugs targeting
rare (orphan) neuromuscular and neurological diseases and disorders, announced
today 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.
The DMC is a group of experts responsible for the independent review of
accumulated clinical safety and efficacy data obtained in our clinical trial,
in order to safeguard the interests and safety of participants and future
patients. 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.
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