FDA OKs Phase 3b trial design for NurOwn in less advanced ALS

The U.S. Food and Drug Administration (FDA) has agreed on the design of a Phase 3b trial that will test the investigational cell-based therapy NurOwn (debamestrocel) in amyotrophic lateral sclerosis (ALS) patients with less advanced disease. The developer, BrainStorm Cell Therapeutics, plans to launch the trial…

Analyses of Cytokinetics’ Clinical Data Provide Insights on ALS Care, Trial Design

Exploratory analysis of data collected in the FORTITUDE-ALS and VITALITY-ALS trials sponsored by Cytokinetics provide new insights to enhance the design of future clinical trials in amyotrophic lateral sclerosis (ALS). These findings were discussed at the 29th International Symposium on ALS/MND in Glasgow, Scotland, in several poster…