BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn Expanded Access Program at 2024 Annual NEALS Meeting (PRNewswire) - Oct 28, 2024 - P=NA | N=NA | NCT04681118 | Sponsor: Brainstorm-Cell Therapeutics | "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)...At the last available visit in the EAP, 9/10 participants were alive. The survival curves revealed a statistically significant difference in favor of debamestrocel (LRT, p= 0.0379) with a median survival time of 46.6 months for the debamestrocel group compared to 41.1 months for the matched control. Among the six 'early-start' participants (those who had received Debamestrocel during the Phase 3 study), a continual reduction in NfL was observed. In contrast, for those who received placebo in the Phase 3, the group median NfL change was 37% by the end of phase 3, indicating worsening neurodegeneration. However, after these participants received debamestrocel in the EAP, the majority showed a stabilization in NfL levels."
Clinical data • Amyotrophic Lateral Sclerosis • CNS Disorders
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