Core Insights - BrainStorm Cell Therapeutics Inc. will present new biomarker data at the Annual ALS Drug Development Summit, indicating that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn®) [1][2] - The data suggests a consistent reduction in neurofilament light (NfL) levels among participants treated with NurOwn, indicating potential benefits from extended treatment [2][3] Company Overview - BrainStorm Cell Therapeutics Inc. specializes in developing adult stem cell therapeutics for neurodegenerative diseases, particularly ALS [6][8] - The NurOwn® technology platform utilizes autologous MSC-NTF cells, which are designed to secrete neurotrophic factors targeting neurodegenerative diseases [6][8] Clinical Trial Insights - The Phase 3 NurOwn trial included an Expanded Access Program (EAP) where participants received a total of 6 doses of NurOwn over two 28-week periods [3] - Participants treated with NurOwn showed an 11% decline in NfL from baseline during the Phase 3 trial, while those on placebo maintained similar NfL levels [3] - In the EAP, participants randomized to NurOwn experienced a 4% decrease in NfL in Phase 3, followed by a 27% and 36% decrease at the end of Period 1 and Period 2, respectively [3] Future Directions - BrainStorm aims to confirm the findings from the EAP in the planned Phase 3b trial of NurOwn [3][7] - The company is actively engaging with the ALS community and regulatory bodies to further its research and development efforts [5][8]
BrainStorm Cell Therapeutics to Present New Biomarker Data Suggesting ALS Patients May Benefit From Longer-Term Treatment with NurOwn