FDA Calendar

Tuesday, June 21, 2011

$CYTK Announces Opening of Next Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis



Cytokinetics Announces Opening of Next Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis - MarketWatch
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"SOUTH SAN FRANCISCO, CA, Jun 21, 2011 (MARKETWIRE via COMTEX) -- Cytokinetics, Incorporated CYTK 0.00% announced today that the company has opened enrollment in a second Phase II clinical trial of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS). CK-2017357, a fast skeletal muscle troponin activator, selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, which increases skeletal muscle force in response to neuronal input and delays the onset and reduces the degree of muscle fatigue. CK-2017357 is the lead drug candidate that has emerged from the company's skeletal muscle contractility program.
This clinical trial is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and tolerability of multiple doses of CK-2017357 in patients with ALS. An estimated 24 patients are planned to be enrolled at eight to ten study centers in the United States. Patients in the trial will be randomized to one of four different treatment groups, to receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357, respectively, for two weeks; clinical assessments will take place at pre-determined times during the course of treatment. Patients will also participate in follow-up evaluations one week after their final dose"

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