Pharma Live: Cytokinetics amending errors in Amyotrophic Lateral Sclerosis Phase IIB Study

computerCytokinetics (CYTK) is a clinical stage biotechnology company that focuses on the discovery and development of novel molecular therapeutics in relation to muscle function. Their current study is on the evaluation of neuromuscular effects and functional improvement with their drug Tirasemtiv in amyotrophic lateral sclerosis (ALS).

The study was halted during its Phase IIb ALS Study because of a reported a placebo error. The data management vendor detected a programming error causing 58 patients to receive the placebo instead of Tirasemtiv. Now that the trial error has been detected, the company is taking the proper precautionary measures to make sure a problem like this does not arise again. Cytokinetics has been in constant communication with regulatory authorities in how to best respond to the error, evaluate the safety of those 58 patients that were mis-dosed, and to preserve the scientific value of this study.

Tirasemtiv has already been granted orphan drug status by the FDA and is planning to collaborate with Astellas Pharma to develop a skeletal muscle activator. These future projects lie on the validity of data and the success of current trials, which Cytokinetics is on the right track of amending. Market Cap: $181.5 million; Volume: 235,330 shares; 12 Month Trail: $2.20-$4.93.

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