Pluristem Therapeutics (NASDAQ:PSTI) reported disappointing results from an interim analysis of its Phase 3 study evaluating PLX-PAD for the treatment of critical limb ischemia.
Based on the interim analysis, the study population experienced a substantially low number of events – including major amputation of the index leg, or death – compared with the known rate of these events in this patient population. In addition, there was a lower than anticipated event rate in the placebo group.
The independent data monitoring committee that conducted the analysis concluded the study is unlikely to meet its primary endpoint by the time of the final analysis. As a result, Pluristem has decided to terminate the study.
“In light of the data monitoring committee’s recommendation, we decided that it would be in the best interests of the company and its shareholders to terminate the critical limb ischemia study and focus our resources and efforts on our other lead indications,” Yaky Yanay, Pluristem’s president and CEO, said in a statement.
“We believe our platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas,” he added.
