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December 7, 2012
07:36 EDTCYTKCytokinetics presents analyses from Tirasemtiv clinical trials in ALS patients
Cytokinetics announced a platform presentation of pharmacokinetic data and pharmacokinetic/pharmacodynamic analyses from three previously-reported clinical trials of tirasemtiv in patients with amyotrophic lateral sclerosis, or ALS, at the 23rd International Symposium on ALS and Motor Neurone Diseases, or ALS/MND, in Chicago, IL. Tirasemtiv selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, which increases skeletal muscle force in response to neuronal input. In preclinical studies, this mechanism has been shown to delay the onset and reduce the degree of muscle fatigue. Tirasemtiv is currently being evaluated in BENEFIT-ALS, an international, double-blind, randomized, placebo- controlled, Phase IIb clinical trial designed to evaluate the safety, tolerability and potential efficacy of this novel drug candidate in patients with ALS.
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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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