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Pluristem (PSTI) FDA Clearance for P2 Trial in Intermittent Claudication (IC)
FDA has granted clearance to start a P2 trial using PLX-PAD cell product candidate for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).
PSTI’s IC P2 trial will evaluate the safety and efficacy of 2 doses (150×106 and 300×106) of PLX-PAD cells versus placebo administered via 2 intramuscular injections (day 1 and week 12 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 US clinical sites.
The Bottom Line: The primary efficacy end point of the trial will be the change in the Maximal Walking Distance from baseline during Exercise Treadmill Test. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed. What happened to the CLI trial status? PSTI has fallen 11% YTD. The shares gained 6.5% to 8.799 shekels in preUS trading. 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.
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