BrainStorm Cell Therapeutics Inc. has announced the U.S. Food and Drug Administration's clearance for the initiation of a Phase 3b clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The trial, which was developed in agreement with the FDA's Special Protocol Assessment, is designed to enroll approximately 200 participants at leading academic medical centers. It will comprise a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension. The primary endpoint of the study is the change in the ALS Functional Rating Scale-Revised from baseline to week 24. The company has scheduled an investor call and webcast to discuss this development further.
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