Biomarker data suggest ALS patients may benefit from longer-term treatment with NurOwn Poster highlighting design of planned Phase 3b NurOwn trial also presented NEW YORK , Oct. 28, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI ), a leading developer of cellular therapies for neurodegenerative diseases, today announced the presentation of two posters featuring NurOwn® (MSC-NTF0 or debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting , which took place virtually October 21 – 24.
The posters 'Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program' and 'An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS' highlight the results achieved with ALS patients who participated in the Expanded Access Program (EAP) for NurOwn and summarize the details of BrainStorm's upcoming Phase 3b trial in ALS. Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program ( Bob Dagher et al) Ten participants (6 debamestrocel, 4 placebo) from Brainstorm's prior Phase 3 clinical trial (BCT-002-US) were enrolled in an open label Expanded Access Program (EAP). The EAP spanned two 28-week periods, with a break in time between the periods.
Participants received an intrathecal dose of Debamestrocel every 8 weeks, for a maximum of 6 doses over the 2 periods. Baseline characteristics from 10 EAP participants, captured at the time they entere.