Pluristem Therapeutics Inc. announced that the company’s Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem’s strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017. In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. With poor treatment options, CLI patients who cannot undergo revascularization procedures have a severe unmet medical need. Pluristem’s Phase III CLI study will be a double blind, randomized, placebo controlled trial of about 250 patients with CLI Rutherford Category 5 who are unsuitable for revascularization. At an estimated 40 clinical sites in the U.S. and Europe, patients will be treated with 300 million PLX-PAD cells or placebo, injected twice intramuscularly (IM), with the second injection administered two months after the first. The primary endpoint is time to amputation or death. The European Medicines Agency (EMA) previously selected the PLX-PAD program in CLI for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal study.