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BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel

 
• By Sue Sutter

In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.

Magic hat
Adcomm members were not persuaded by what one panelist called BrainStorm's 'statistical magic' on the failed Phase III trial. • Source: Shutterstock

A US Food and Drug Administration advisory committee resoundingly concluded that BrainStorm Cell Therapeutics Inc. has not proven NurOwn (debamestrocel) is effective in treating amyotrophic lateral sclerosis, with panelists going well beyond just the clinical data in identifying problems with the application.

At a 27 September meeting, the Cellular, Tissue and Gene Therapies Advisory Committee voted 17-1, with one abstention, that the data presented do not demonstrate substantial

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