Regulatory Clearance for Phase 3b Trial
The U.S. FDA has cleared Brainstorm Cell Therapeutics to initiate the Phase 3b trial for NurOwn, marking a significant milestone in their ALS treatment development.
Strong Interest from Clinical Sites
Brainstorm is negotiating with approximately 15 leading clinical centers across the United States for their Phase 3b trial, highlighting strong interest and support from renowned ALS clinicians and researchers.
Positive Biomarker Research
Significant changes in biomarkers were observed in the study, showing NurOwn's potential multimodal mechanism of action, including neuroprotective and anti-inflammatory effects.
Exosome Program Progress
Promising preclinical data from Brainstorm's exosome program demonstrates therapeutic effects in models of lung disease, with active pursuit of strategic partnerships for clinical development.