BrainStorm Announces Scientific Presentation at the Annual NEALS Meeting Presentation outlines design of pivotal Phase 3 trial evaluating NurOwn® as a treatment for ALS Trial remains on track for topline data in 4Q-2020
NEW YORK, Sept. 30, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting, being held virtually. The poster, which will be presented virtually today by Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at Brainstorm, details the design of the Company's placebo-controlled, randomized, double-blind, Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS patients.
"This pivotal study has been rigorously designed and powered to detect clinically meaningful effects of NurOwn® in rapidly progressing ALS patients," said Dr. Lindborg. "Compelling Phase 2 data showed that a single NurOwn® administration slowed disease progression in this patient population, and the current Phase 3 trial aims to confirm this effect in a larger study cohort and show that its duration can be extended through repeated administrations. To test this hypothesis, we are comparing the rate of patient level decline in ALS disease as measured by the ALS Functional Rating Scale between the pre-treatment period to the rate of decline observed after the initiation of treatment. Such an analysis allows us to compare the magnitude of change in disease progression resulting from NurOwn® and placebo treatments while accounting for important variable factors known to influence disease progression. We look forward to sharing the results of this analysis later this year."
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