Cytokinetics Says 58 in ALS Trial Got Placebo in ErrorAlex Nussbaum
Cytokinetics Inc. is evaluating the costs and timing of a clinical trial for its amyotrophic lateral sclerosis treatment after some patients were given a placebo by mistake. The shares fell as much as 8.8 percent.
Fifty-eight patients slated to receive the drug, called tirasemtiv, were instead given the placebo due to a computer programming error, the South San Francisco, California-based company said in a statement today. The error has been fixed and the trial is continuing, Cytokinetics said. No participants assigned to the control group were given the treatment.
Tirasemtiv treats amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease, a fatal breakdown of the central nervous system with no known cure. The trial, designed to enroll as many as 500 patients, was in the second of three stages usually required to win marketing approval in the U.S.
“Cytokinetics is in communication with regulatory authorities regarding how best to respond to the error in drug assignment in order to preserve the intended scientific value” of the trial, the company said. Enrollment could be expanded and Cytokinetics may also need to make revisions to the timing of results and projected costs, according to the statement.
Cytokinetics shares, which have more than tripled this year, dropped 6.5 percent to $11.98 at 9:37 a.m. New York time, after declining to $11.68. The shares had surged this year as the company announced partnerships with drugmakers Amgen Inc. and Astellas Pharma Inc.