Pluristem Gets Israel Approval To Begin Phase II Study In IC - Quick Facts

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), a developer of placenta-based cell therapies, announced that the Israeli Ministry of Health has approved the company's request to initiate a Phase II study using its PLacental eXpanded or PLX cells in the treatment of Intermittent Claudication or IC, a subset of peripheral artery disease or PAD.

The company said the approval is part of its previously announced strategy to conduct a multi-national study for this indication. The firm stated that protocol will be the same one used for the study previously approved in the U.S.

Pluristem's IC Phase II is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.

The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.