UPDATE: Cytokinetics Halted News Disseminated: Issues Update on BENEFIT-ALS, Says 58 Patients Received Placebo Instead of Drug

Cytokinetics, Incorporated (Nasdaq: CYTK) announced today an update on the conduct of BENEFIT-ALS (BlindedEvaluation of Neuromuscular Effects and Functional Improvement with Tirasemtivin ALS).  BENEFIT-ALS is a Phase IIb, multinational, double-blind, randomized,placebo-controlled clinical trial designed to evaluate the safety,tolerability and potential efficacy of tirasemtiv, a fast skeletal muscletroponin activator, in patients with amyotrophic lateral sclerosis (ALS).BENEFIT-ALS is currently designed to enroll up to 500 patients with ALS.  Todate, over 450 patients have been enrolled in this study.   The primaryanalysis of BENEFIT-ALS will compare the mean change from baseline in the ALSFunctional Rating Scale in its revised form, or ALSFRS-R (a clinicallyvalidated instrument designed to measure disease progression and changes infunctional status), in patients receiving tirasemtiv versus those receivingplacebo.Cytokinetics was recently informed by its data management vendor that aprogramming error in the electronic data capture system controlling study drugassignment caused 58 patients initially randomized to and treated withtirasemtiv to receive placebo instead at a certain study visit and for theremainder of the study.   No patients randomized to placebo were dispensedincorrect treatment.   Cytokinetics and all clinical trial site personnelremain blinded to the specific patients affected by the error.Since the error was detected, the company has taken steps to ensure that nofurther incorrect study drug assignments have occurred and the programmingerror in the electronic data capture system controlling study drug assignmenthas been corrected.    In addition, the company recently convened an ad hocmeeting of the study's Data Safety Monitoring Board (DSMB) to assess whetherthe error in dispensing study drug had impacted the safety of the 58 affectedpatients.  After review of the relevant safety data from BENEFIT-ALS, the DSMBreported no concerns regarding patient safety. Cytokinetics is in communication with regulatory authorities regarding howbest to respond to the error in drug assignment in order to preserve theintended scientific value of BENEFIT-ALS.  The company continues to enrollpatients in the study under the current protocol and may amend the protocol toallow increased enrollment.  Following further communications with regulatoryauthorities, Cytokinetics expects to provide updated guidance relating to theconduct of BENEFIT-ALS, which may include revisions to the timing of publiclyavailable results from the study as well as to the projected costs of thestudy.