Cytokinetics Amends ALS Therapy Trial After MistakeMeg Tirrell
Cytokinetics Inc., the developer of an experimental drug for amyotrophic lateral sclerosis, said it will increase the number of patients in a trial of the therapy after some were given a placebo by mistake.
After talking with regulators, Cytokinetics expanded the trial to include about 680 patients and updated the statistical methods section. The changes are expected to increase trial costs by about $5 million this year and next, the South San Francisco, California-based company said today in a statement.
A programming error controlling study drug assignment caused 58 patients that should have been treated with the drug, tirasemtiv, to instead be given a placebo, Cytokinetics said July 8. More than 500 patients have been enrolled so far in the trial, which is in the second of three phases generally required for regulatory approval.
The company said enrollment is expected to be completed in the second half of this year, with results available in early 2014. ALS, or Lou Gehrig’s disease, is a fatal breakdown of the central nervous system with no known cure.
Cytokinetics fell 4.5 percent to $13.10 at the close in New York. The shares have tripled this year.