Cytokinetics completes review results from BENEFIT-ALS regarding tirasemtiv Cytokinetics provided a program update today relating to tirasemtiv, the company's lead drug candidate from its skeletal muscle contractility program. The company announced that it has completed its review of results from BENEFIT-ALS and has concluded that effects observed on Slow Vital Capacity in patients treated with tirasemtiv are robust and potentially clinically meaningful. In addition, following consultation with clinical and statistical experts, the company believes that data from BENEFIT-ALS support progression of tirasemtiv to a potential Phase III clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company also announced that it has begun regulatory interactions with the U.S. Food and Drug Administration regarding results from BENEFIT-ALS and has received initial feedback from the FDA. The company believes that effects on SVC could be a Phase III clinical trial endpoint and could support registration of tirasemtiv as a potential treatment for patients with ALS. As a result, Cytokinetics has initiated planning for a potential Phase III clinical trial of tirasemtiv that could begin in 2015. Cytokinetics has received feedback from the FDA following initial communications regarding tirasemtiv and BENEFIT-ALS. The company believes that the FDA may be willing to consider a potential registration path for tirasemtiv relating to effects on SVC. The company expects to have additional interactions with the FDA and other regulatory authorities. In addition, the company has commenced Phase III readiness activities including designing a potential Phase III clinical trial in order to inform plans, timelines and costs associated with the further development of tirasemtiv.