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BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

 
• By Sue Sutter

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

ALS On Chalkboard
The ALS patient community is eager for new treatments. • Source: Shutterstock

The US Food and Drug Administration’s unusual public statement about an investigational drug to treat ALS may be aimed at tamping down the sponsor’s bullish comments to the patient community about its Phase III data and prospects for regulatory approval.

On 2 March, the Center for Biologics Evaluation and Research quietly posted a statement on its website commenting on the status of the development program for BrainStorm Cell Therapeutics Inc

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