Haifa, Israel –April 17, 2012 — Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), announced today that the United States Food and Drug Administration (FDA) has granted the company clearance to start a Phase II clinical trial using the company’s PLX-PAD cell product candidate for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).
Pluristem’s IC Phase II trial will evaluate the safety and efficacy of two doses (150×106 and 300×106) of PLX-PAD cells versus placebo administered via two intramuscular injections (day one and week twelve post initial injection). The study population will be comprised of 132 patients (44 in each cohort) with IC, Fontaine class IIb; Rutherford category 2-3, in approximately 10 U.S. clinical sites.
The primary efficacy end point of the trial will be the change in the Maximal Walking Distance from baseline during an Exercise Treadmill Tests. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed.
“We are excited to receive the world’s FDA first clearance for an Intermittent Claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for IC”, said Zami Aberman, Chairman and CEO of Pluristem. “We believe that our approach of repeatable intramuscular injections will potentially enable to boost the healing process of our patients. In this trial, we will take benefit of our “off-the-shelf” PLX properties achieved by our three dimensional (3D) proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of IC patients around the world.”
