Pluristem plunges as CLI trial unlikely to meet primary endpoint, study terminated

 

• Pluristem Therapeutics (NASDAQ:PSTI) slumps 42% premarket in reaction to recommendation letter by the independent Data Monitoring Committee (DMC) of its global Phase III study for the treatment of critical limb ischemia (CLI).
• The clinical dataset was reviewed for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death.
• Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis.
• Substantial low number of events in the placebo group in the CLI study decreased the statistical power of the study to meet its primary endpoint.
• PLX-PAD was well tolerated and no significant safety concerns were raised during the study.
• Following the DMC’s recommendation, the Company decided to terminate the CLI study to focus on different therapeutic areas.
• https://seekingalpha.com/news/3642871-pluristem-plunges-42-cli-trial-unlikely-to-meet-primary-endpoint-study-terminated