BioCentury
ARTICLE | Company News

Cytokinetics discloses dosing problems with ALS trial

July 8, 2013 11:34 PM UTC

Cytokinetics Inc. (NASDAQ:CYTK) said 58 patients initially treated with twice-daily, oral tirasemtiv were accidentally switched to placebo in the Phase IIb BENEFIT-ALS trial to treat amyotrophic lateral sclerosis. The company said it was notified of the issue by its data management vendor, which attributed the issue to a programming error. Cytokinetics said it "is in communication with regulatory authorities" about how to address the error. The company said it will provide an update on whether it will need to increase enrollment in the trial and when it expects to release data from the trial, but did not disclose details. Cytokinetics has enrolled over 450 of a planned 500 ALS patients in the trial. The company previously said data were expected this year. Tirasemtiv, a fast skeletal muscle troponin activator, also is in Phase II testing to treat myasthenia gravis and claudication associated with peripheral artery disease (PAD). ...