Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), has been granted clearance from the FDA 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.
Intermittent Claudication (IC) is a subset of Peripheral Artery Disease (PAD) caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient Data).
Pluristem’s PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration.