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BrainStorm's Cell Therapy Disappoints In Phase III ALS Study

But Subgroup Analysis Encouraging

 
• By John Davis

Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.  

amyotrophic lateral sclerosis
• Source: Shutterstock

BrainStorm Cell Therapeutics Inc.’s adult stem cell therapy, NurOwn, has missed the primary efficacy endpoint in top-line results from a Phase III study in amyotrophic lateral sclerosis (ALS), disappointing investors, although clinical investigators involved in the study were encouraged by the results. 

The study included more severely affected patients than other ALS studies, and the US Food and Drug Administration will review the data “to see if there is a path forward...

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