- The CLI study is unlikely to meet its 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 safety concerns were raised
- Company to terminate the CLI study to focus on different therapeutic areas in its pipeline and expects three clinical readouts within the coming calendar year
Pluristem Therapeutics, a leading regenerative medicine company developing a platform of novel biological therapeutic products, today announced that the independent Data Monitoring Committee (DMC) of its global pivotal Phase III study for the treatment of critical limb ischemia (CLI) issued its recommendation letter following the interim analysis. The clinical dataset was reviewed by the independent DMC 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. The DMC advised the Company that the CLI study population has experienced a substantial low number of events (major amputation of the index leg or death), different from what is known in clinical medicine for the rate of these events in this patient population. The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint.
DMC noted that 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. Currently, the Company continues to be blinded to the CLI study clinical data.
“We are deeply disappointed by the outcome of the CLI interim analysis. In light of the DMC’s recommendation, we decided that it would be in the best interests of the Company and its shareholders to terminate the CLI study and focus our resources and efforts on our other lead indications,” stated Pluristem CEO and President, Yaky Yanay.
“We expect to present topline clinical results during calendar year 2021, including our Phase III study in muscle regeneration following hip fracture, Phase II studies in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 and our Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). Pluristem is well positioned to advance and support future development of these indications.”
“Throughout the years, we have developed unique and propriety expertise, knowhow and intellectual property, alongside a diverse clinical pipeline and we possess a state-of-the-art cell manufacturing facility. We believe our platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas,” Mr. Yanay concluded.