Cytokinetics, Inc. (CYTK) completed recruitment and enrolment of patients for its phase IIb BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) study on tirasemtiv. The phase IIb study is evaluating the safety, tolerability and efficacy of tirasemtiv in patients suffering from amyotrophic lateral sclerosis (ALS).
Cytokinetics will mainly compare the mean change in the ALS Functional Rating Scale from baseline in its revised form (ALSFRS-R) on tirasemtiv against placebo in the study. Other objectives of the study include Maximum Voluntary Ventilation (MVV) and other measures of respiratory and skeletal muscle function and fatigability. Cytokinetics intends to report results from the study in the first half of 2014.
Tirasemtiv, Cytokinetics’ lead candidate under its skeletal muscle contractility program, was well tolerated in phase IIa clinical studies in patients suffering from ALS. The candidate also demonstrated improvement in functional abilities and increases in measures of respiratory and skeletal muscle strength and endurance of the patients.
We note that in Jul 2013, Cytokinetics had reported a programming error in the BENEFIT-ALS study. Cytokinetics’ data management vendor reported that due to a programming error in the electronic data capture system controlling study drug assignment, 58 patients received placebo instead of tirasemtiv at a certain study visit.
The company however said that no incorrect treatment was conducted on the patients in the placebo arm. Cytokinetics also conducted an ad hoc meeting of the study’s Data Safety Monitoring Board (DSMB) to clarify that the safety of the 58 patients affected by the error had not been impacted. The DSMB reviewed the safety data and reported that there were no concerns regarding patient safety.
Cytokinetics currently carries a Zacks Rank #3 (Hold). Some better ranked stocks include Actelion Ltd. (ALIOF), Lannett Company, Inc. (LCI) and AMAG Pharmaceuticals, Inc. (AMAG). All the stocks carry a Zacks Rank #1 (Strong Buy).
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