BrainStorm Cell Therapeutics Inc. Announces Phase 3b Trial for ALS Treatment NurOwn, Reaffirming Commitment to Advancing Patient Access
Reuters
Jul 08
BrainStorm Cell <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Inc. Announces Phase 3b Trial for ALS Treatment NurOwn, Reaffirming Commitment to Advancing <a href="https://laohu8.com/S/PASO">Patient Access</a>
BrainStorm Cell Therapeutics Inc. has announced its commitment to proceed with a planned Phase 3b clinical trial, named ENDURANCE, for its treatment NurOwn, targeting amyotrophic lateral sclerosis (ALS). The trial will be conducted under an FDA Special Protocol Assessment $(SPA.UK)$ to generate additional robust data and confirm NurOwn's efficacy and safety in early-stage ALS patients. This development comes as the U.S. Food and Drug Administration (FDA) is set to review a Citizen Petition requesting a new evaluation of the data supporting NurOwn. While BrainStorm was not involved in drafting the petition, the company welcomes the FDA's willingness to reassess the existing data. The results of the Phase 3b trial have not yet been presented, as the trial is planned for future implementation.
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