- BrainStorm Cell Therapeutics (BCLI, Financial) to present breakthrough pharmacogenomic data at ISCT 2025, focusing on UNC13A genotype in ALS treatment.
- Phase 3b trial preparations for NurOwn are underway, with positive FDA communication and IND amendment submission.
- Presentation scheduled for May 8, 2025, to explore treatment response predictive genetic factors.
BrainStorm Cell Therapeutics Inc. (BCLI), a prominent player in the cellular therapy domain, has announced the inclusion of its new pharmacogenomic data in the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. This presentation, selected as breakthrough science, will delve into how the UNC13A genotype affects response to NurOwn® (debamestrocel) in amyotrophic lateral sclerosis (ALS) patients. The event is set to take place from May 6-10, 2025, in New Orleans.
The scheduled presentation on May 8, 2025, will detail the effects of debamestrocel on clinical and biomarker endpoints, correlating them with UNC13A genotype variations. This marks the first-ever pharmacogenomic analysis from NurOwn's Phase 3 trial, aimed at unraveling genetic factors that influence treatment outcomes.
BrainStorm is gearing up for a Phase 3b trial of NurOwn in early ALS treatment, having received positive feedback from the FDA regarding their submitted Investigational New Drug (IND) amendment. Implementing a Special Protocol Assessment (SPA) as agreed with the agency, the company is strategically positioned to initiate this trial, though specific dates remain unconfirmed.
These insights are expected to contribute significantly to ALS treatment strategies, potentially enabling personalized medicine approaches by identifying patients most likely to benefit from specific therapeutic interventions. The presentation signifies a substantial step in advancing NurOwn's clinical application and development.
