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BrainStorm: Phase 3 Trial With NurOwn Fails To Meet Statistical Significance In Efficacy Endpoint

BrainStorm Cell Therapeutics Inc. (BCLI) reported topline results from double-blind placebo-controlled phase 3 trial evaluating NurOwn as a treatment for Amyotrophic lateral sclerosis. The trial did not reach statistically significant results. The company noted that this clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.

NurOwn was generally well tolerated, and showed a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints.

"We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data. The FDA will review the data to see if there is a path forward to support approval," said Chaim Lebovits, CEO of BrainStorm.

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