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Phase 3b Trial Design Unveiled at Clinical/Scientific Conference

BrainStorm Cell Therapeutics

Planned Phase 3b trial Designed to Confirm Efficacy and Safety of NurOwn in mild-to-moderate ALS patients

NEW YORK, Feb. 27, 2024 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will present a poster (#M201) outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS) at the MDA Clinical and Scientific Conference, on Monday, March 4 between 6-8 p.m. at the Hilton Orlando Hotel, Florida. The design is for a two-part, multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with ALS. Eligible patients will initially enter a 24-week randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension period (Part B). The entry criteria will enroll people living with mild-to-moderate ALS. The primary endpoint will be based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

BrainStorm recently submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for this Phase 3b study of NurOwn. A SPA agreement would indicate concurrence by FDA with the adequacy and acceptability of the overall protocol design for the planned Phase 3b study, intended to support a future marketing application. The details are currently under review by the FDA and the company plans to finalize the details following the receipt of input from the Agency.

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