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Pluristem Therapeutics Inc.announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed Phase III trial of its PLX-PAD cells in the treatment of critical limb ischemia (CLI). This Phase III trial is intended to support a biologics license application (BLA).
The Phase III study is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first.
The primary endpoint will be time to amputation and death (amputation free survival). Clinical sites will enroll patients in the U.S. and Europe.
In parallel, the study protocol has been submitted as a single pivotal trial to European national competent authorities, following scientific advice from the European Medicines Agency (EMA), and approval is expected in the upcoming months. Pluristem’s intention is to utilize this 250 patient trial as a single pivotal trial to apply for regulatory approval in both the U.S. and Europe. “This is a significant leap forward for Pluristem, as we prepare to enter into a U.S. Phase III trial with our cell therapy for the treatment of CLI.
There are few treatment options for this serious cardiovascular condition, which too often leads to amputation and death. We look forward to starting this trial by early 2017,” stated Pluristem Chairman and CEO Zami Aberman. “Concurrent with this U.S. FDA process, we are also moving the CLI indication forward in Europe and Japan. Our PLX-PAD cells address a $12 billion global market in the treatment of CLI.”
In May 2015, the EMA’s Adaptive Pathways Pilot Project selected the PLX-PAD program for the accelerated pathway, which may lead to conditional marketing approval following a single successful pivotal study
