Pluristem Therapeutics Inc. (Nasdaq: PSTI) share nose-dived in the premarket session after the announcement by a leading regenerative medicine firm building a marketplace for new biotherapeutic drugs that the Independent Data Management Committee (DMC) of its global pivotal Phase III trial for the treatment of critical limb ischemia (CLI) released its recommendation letter after an interim review.
An unbiased DMC checked the clinical dataset to protect and examine the primary endpoint of amputation-free survival, identified as the time for significant amputation of the index leg or death.
Based on the evaluation, the DMC concluded that the CLI thesis is unlikely to reach the primary endpoint at the time of the final report. The lower than predicted case occurrence in the placebo community decreased the analysis’s predictive capacity to reach its primary endpoint.
DMC noted that PLX-PAD was well tolerated and that no significant safety issues were posed during the analysis.
Following the advice of the DMC, the Organization agreed to terminate the CLI report. The business appears to be blinded to clinical evidence from the CLI report.