Cytokinetics (CYTK) Announces Completion of VITALITY-ALS Patient Enrollment

August 17, 2016 7:33 AM EDT

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Cytokinetics, Inc. (Nasdaq: CYTK) announced the completion of patient enrollment in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an international Phase 3 clinical trial of tirasemtiv in patients with ALS. VITALITY-ALS is designed to assess the effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of skeletal muscle strength in patients with ALS. VITALITY-ALS enrolled more than 700 patients in 81 centers in 11 countries. Results from VITALITY-ALS are expected in the second half of 2017. The company also announced that enrollment in the open-label extension to VITALITY-ALS is expected to begin in the fourth quarter of this year.

“Completion of enrollment in VITALITY-ALS marks a significant milestone for Cytokinetics as well as the ALS community as we take another step toward advancing what could be the first potential new medicine for people with ALS in more than 20 years,” said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President, Research & Development. “We would like to express our thanks to the dedicated investigators and clinical site coordinators who are conducting the trial and also patients with ALS and their caregivers who are participating. We look forward to reporting results in the second half of 2017.”

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