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March 27, 2014
07:36 EDTCYTKCytokinetics initiates multiple dose Phase I clinical trial of CK-2127107
Cytokinetics (CYTK) announced the initiation of an additional Phase I clinical trial of CK-2127107, a fast skeletal muscle troponin activator. The trial, called CY 5012, is a double-blind, randomized, placebo-controlled, parallel group study in which the primary objective is to assess the safety, tolerability, and pharmacokinetics of CK-2127107 following multiple ascending doses in healthy volunteers. The initiation of this clinical trial triggers a $2M milestone payment from Astellas Pharma (ALPMF) to Cytokinetics under the terms of the collaboration between the companies established in June 2013. In CY 5012, volunteers in each ascending dose cohort will be randomized to receive either CK-2127107 or placebo. CY 5012 will separately enroll cohorts of volunteers in two age groups, one between the ages of 18 and 55 and one between the ages of 65 and 85. Each cohort will be comprised of six male and six female participants. In each cohort, volunteers will receive CK-2127107 or placebo in accordance with 2:1 randomization. An initial cohort in each age group will receive 300 mg of CK-2127107 or placebo to be followed by a second cohort in each age group that will receive 1000 mg of CK-2127107 or placebo. Doses of CK-2127107 and placebo will be administered orally for 10 days. If these doses of CK-2127107 are well-tolerated, a final cohort of volunteers between the ages of 18 and 55 will receive CK-2127107 at either 1500 mg or 2000 mg, to be determined following a review of data from the prior dose cohorts or placebo. In each cohort, pharmacokinetic assessments will be performed following the first dose of CK-2127107 and throughout the study to day 10.
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October 27, 2014
07:39 EDTCYTKCytokinetics provides development program update for omecamtiv mecarbil
Cytokinetics provided an update relating to omecamtiv mecarbil, the company's lead drug candidate from its cardiac muscle contractility program. The company announced that COSMIC-HF, or Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, has enrolled over 275 patients towards the objective of 450 patients in the ongoing expansion phase of the trial. In addition, over 70 patients have completed the 20 weeks of dosing in the expansion phase of COSMIC-HF. Recently, the Data Monitoring Committee reviewed data from COSMIC-HF and recommended that the trial continue without any changes to the protocol. Patient enrollment in COSMIC-HF is expected to conclude by the end of 2014. The company also announced that CY 1211, a Phase I study comparing the tolerability and pharmacokinetics of omecamtiv mecarbil between Japanese and Caucasian healthy volunteers, is complete and indicates no clinically meaningful differences between the two groups studied. Data from CY 1211 are expected to inform plans for the development of omecamtiv mecarbil in Japan and the inclusion of Japan in potential global Phase III program activities.
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.

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