Pluristem to terminate Phase III study of critical limb ischemia (CLI)
While the CLI study was unsuccessful, Yanay said the company is maintaining a forward-thinking attitude, looking toward the development of other treatments it has in the works.
By JERUSALEM POST STAFFBiologists work in a laboratory at Pluristem Theraputics in Haifa(photo credit: REUTERS)
Haifa-based Pluristem Therapeutics has received recommendation to terminate its Phase III study monitoring the treatment of critical limb ischemia (CLI) from the independent Data Monitoring Committee (DMC) overseeing it.Pluristem specializes in regenerative medicine therapies, notably cell therapies, which treat inflammation, ischemia, ulcers, muscle trauma, blood disorders and radiation poisoning.Ischemia is a condition where sufficient blood is prevented from reaching a part of the body, be it a limb or an organ.The recommendation states that the Phase III study is unlikely to meet its primary endpoints by the study's end, stating it had "experienced a substantial low number of events different from what is known in clinical medicine for the rate of these events in this patient population."The treatments were well "tolerated," with no considerable safety issues raised during the study. However, in light of the recommendation, Pluristem will be cancelling any further operations forwarding the CLI study."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,” said Pluristem CEO and president Yaky Yanay.While the CLI study was unsuccessful, Yanay said the company is keeping a forward-thinking attitude, looking towards the development of other treatments it has impending."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 [blood cell component formation] recovery following hematopoietic cell transplantation (HCT)," Yanay added. "Pluristem is well positioned to advance and support future development of these indications."Throughout the years, we have developed unique and proprietary expertise, know-how and intellectual property alongside a diverse clinical pipeline, and we possess a state-of-the-art cell manufacturing facility," Yanay said. "We believe our platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas."
