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Cytokinetics, Incorporated
announced today an update on the conduct of BENEFIT-ALS (Blinded
Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv
in 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 muscle
troponin activator, in patients with amyotrophic lateral sclerosis (ALS).
BENEFIT-ALS is currently designed to enroll up to 500 patients with ALS. To
date, over 450 patients have been enrolled in this study. The primary
analysis of BENEFIT-ALS will compare the mean change from baseline in the ALS
Functional Rating Scale in its revised form, or ALSFRS-R (a clinically
validated instrument designed to measure disease progression and changes in
functional status), in patients receiving tirasemtiv versus those receiving
placebo.
Cytokinetics was recently informed by its data management vendor that a
programming error in the electronic data capture system controlling study drug
assignment caused 58 patients initially randomized to and treated with
tirasemtiv to receive placebo instead at a certain study visit and for the
remainder of the study. No patients randomized to placebo were dispensed
incorrect treatment. Cytokinetics and all clinical trial site personnel
remain blinded to the specific patients affected by the error.
Since the error was detected, the company has taken steps to ensure that no
further incorrect study drug assignments have occurred and the programming
error in the electronic data capture system controlling study drug assignment
has been corrected. In addition, the company recently convened an ad hoc
meeting of the study's Data Safety Monitoring Board (DSMB) to assess whether
the error in dispensing study drug had impacted the safety of the 58 affected
patients. After review of the relevant safety data from BENEFIT-ALS, the DSMB
reported no concerns regarding patient safety.
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 BENEFIT-ALS. The company continues to enroll
patients in the study under the current protocol and may amend the protocol to
allow increased enrollment. Following further communications with regulatory
authorities, Cytokinetics expects to provide updated guidance relating to the
conduct of BENEFIT-ALS, which may include revisions to the timing of publicly
available results from the study as well as to the projected costs of the
study.
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