In April, we presented data from two different recently Phase II clinical trials in ALS patients. Having now completed four Phase I and four Phase II clinical trials of tirasemtiv that have in total and rolled over 100 volunteers and over 200 patients. We have learned a great deal about the safety, tolerability, pharmacokinetics and pharmacodynamics of tirasemtiv and have selected a dosing regimen for later stage studies of this novel mechanism drug candidate.In addition, through our recent interactions with major regulatory authorities, including the U.S. Food and Drug Administration or FDA, and the European Medicines Agency or EMA, we believe we have identified end points that in upcoming potential registration trials may demonstrate sufficient clinical benefit of tirasemtiv in patients with ALS to support its' potential approval for the treatment of ALS.
Cytokinetics' CEO Discusses Q2 2012 Results - Earnings Call Transcript
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