Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has completed the planned enrollment of 150 patients in a global Phase II trial of its PLacental eXpanded (PLX)-PAD cells for the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). The double blind, randomized, placebo controlled trial enrolled 50 patients since October 2015 in the U.S., Germany, Israel, and South Korea.
Pluristem has expanded the trial to enroll 20 additional patients to be randomized in order to preserve the study’s original design to administer two injections to each of 150 patients. Twenty of the 150 patients originally enrolled did not complete the trial with two injections. Previous findings in clinical and preclinical studies of PLX cells demonstrated the superior efficacy of two injections vs. a single injection in certain indications.
“We have seen a significant increase in the enrollment rate in the last six months, and I eagerly anticipate the final results of this study. As there is significant suffering of patients with peripheral artery disease, the medical field must advance in offering treatment strategies in addition to revascularization or supervised exercise training, which is not suitable for all patients,” stated the study’s Principal Investigator, Prof. Dr. Norbert Weiss, of the Dresden Division of Angiology, Center for Vascular Medicine and Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden in Germany.
“In the last two years we significantly advanced our understanding of the mechanisms of action of PLX cells, and established the importance of repeat injections to stimulate tissue regeneration in certain acute and chronic indications. Based on our recruitment rate in the last half year, we anticipate quickly completing enrollment of the additional patients,” said Pluristem Chairman and CEO Zami Aberman.
About Intermittent Claudication
IC is a subset of peripheral artery disease, caused by atherosclerosis of the lower extremity arteries. 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.
About the Study
Pluristem's Phase II trial is evaluating the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is now comprised of approximately 170 patients with IC, Fontaine class IIb, Rutherford category 2-3. In addition to the primary efficacy endpoint of change in the maximal walking distance from baseline during an exercise treadmill test, secondary endpoints of the study are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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