Core Insights - BrainStorm Cell Therapeutics Inc. announced new survival data from its Expanded Access Program (EAP) for NurOwn® in amyotrophic lateral sclerosis (ALS), highlighting promising long-term survival outcomes for participants [1][4]. Group 1: Survival Data - The EAP included 10 participants who had completed the Phase 3 clinical trial, with survival data analyzed from symptom onset through participation in the trial and EAP [2]. - 90% of participants (9 out of 10) survived more than five years from the onset of ALS symptoms, significantly higher than the approximately 10% survival rate typically expected for ALS patients [7]. - The median survival observed in the EAP cohort was 6.8 years, with a range of 6 to 7 years from symptom onset [7]. Group 2: Clinical Implications - The survival data provide real-world insights into the long-term experience of ALS patients treated with NurOwn, supporting the upcoming Phase 3b clinical trial under FDA Special Protocol Assessment (SPA) [4][8]. - 6 out of 10 patients in the EAP are still alive more than seven years after symptom onset, indicating a clinically meaningful observation [4][7]. - The observed durability of survival underscores the importance of advancing the upcoming registrational Phase 3b controlled clinical trial [4]. Group 3: Technology and Approach - NurOwn® technology utilizes autologous MSC-NTF cells derived from bone marrow, designed to deliver neurotrophic factors and immunomodulatory cytokines to slow or stabilize disease progression in neurodegenerative disorders [5][6]. - The platform has received Orphan Drug designation from both the FDA and the European Medicines Agency (EMA) [8]. - BrainStorm is also advancing a proprietary exosome-based platform for delivering therapeutic proteins and nucleic acids, further enhancing its intellectual property portfolio in regenerative medicine [8].