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April 29, 2014
07:41 EDTCYTKCytokinetics announces additional results from BENEFIT-ALS
Cytokinetics announced additional results from Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS, or BENEFIT-ALS. In BENEFIT-ALS, 711 patients with amyotrophic lateral sclerosis, or ALS, were enrolled into the open-label phase; subsequently 605 patients were randomized 1:1 to double-blind treatment with either tirasemtiv or placebo for 12 weeks. As previously announced, BENEFIT-ALS did not achieve its primary efficacy endpoint. the mean change from baseline in the ALS Functional Rating Scale in its revised form; ALSFRS-R. Secondary endpoints evaluated measures of respiratory performance and other measures of skeletal muscle function and fatigability. Treatment with tirasemtiv resulted in a statistically significant and potentially clinically meaningful reduction in the decline of Slow Vital Capacity that has been shown to be an important predictor of disease progression and survival in prior trials of patients with ALS. This pre-specified secondary efficacy endpoint also declined less on tirasemtiv than on placebo at each assessment time point.
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October 20, 2014
07:37 EDTCYTKCytokinetics 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.
October 13, 2014
07:35 EDTCYTKCytokinetics announces development program update for CK-2127107
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