Pluristem Therapeutics Inc. (PSTI) announced that the independent Data Monitoring Committee of its global pivotal Phase III study for the treatment of critical limb ischemia or CLI issued its recommendation letter that the study is unlikely to meet the primary endpoint by the time of final analysis.
Meanwhile, DMC noted that PLX-PAD was well tolerated and no significant safety concerns were raised during the study.
Following the DMC's recommendation, Pluristem said it has decided to terminate the CLI study.
Pluristem CEO and President, Yaky Yanay, stated "We are deeply disappointed by the outcome of the CLI interim analysis,"
The company said it plans to focus on different therapeutic areas in its pipeline and expects three clinical readouts within the coming calendar year.
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