Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, has completed enrollment of all 172 patients in a multinational phase II trial of its PLX-PAD cells in the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). Enrollment took place at 30 clinical sites in the US, Germany, South Korea, and Israel. IC is characterized by leg cramps and pain while walking, caused by insufficient blood flow through arteries that are partially obstructed by atherosclerotic plaques.

“Completion of enrollment for our phase II IC trial is a major milestone for Pluristem. We expect to report top line results in early 2018, which we intend to use to support our future application for a Biologics License Application (BLA) for approval to commercialize PLX-PAD for the treatment of critical limb ischemia (CLI), another peripheral artery disease. Now that we have completed the enrollment for this important study, Pluristem is ready to move full steam ahead with the enrollment of the recently announced phase III trial in CLI. Our immediate goal is to bring PLX products to market as rapidly as possible,” stated Pluristem chairman and CEO Zami Aberman.

“PLX-PAD cells are a potentially game-changing, non-invasive and much needed treatment for patients all over the world who suffer from peripheral artery disease. I am looking forward to the results of this IC trial, and to initiation of the phase III in CLI (PACE study) this year,” commented Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, principle investigator (PI) for the European part of the Phase II IC trial, and one of the PIs of Pluristem’s upcoming phase III trial in CLI.

“The option of treating peripheral artery diseases like IC and CLI through intramuscular injections of PLX-PAD cells is a promising one and a possible alternative to invasive procedures such as angioplasty or vascular surgery which may not be an option for a substantial portion of patients. Pluristem’s regenerative cell therapy may improve patient care and create economic benefits for the healthcare system,” stated Dr. Manesh Patel, chief of the division of cardiology at Duke University Health System, and the PI for the US part of the phase II IC trial.

Pluristem's IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo. Both were administered via intramuscular injections in 172 patients with IC, Fontaine class IIb, Rutherford category 2-3. The primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints include hemodynamic and quality of life measurements. Safety parameters are also being assessed.

IC is a subset of peripheral artery disease, caused by atherosclerosis of the arteries in the lower extremities. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.