BrainStorm Cell Therapeutics Inc. Receives FDA Clearance to Launch Phase 3b Trial of NurOwn® for ALS
BrainStorm Cell Therapeutics Inc. has received FDA clearance to initiate a Phase 3b clinical trial of NurOwn® for ALS treatment. The trial will enroll around 200 participants at top medical centers and includes a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension. The primary endpoint is the change in the ALS Functional Rating Scale-Revised from baseline to week 24. An investor call and webcast are scheduled to discuss this development further.
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.
