Pluristem (PSTI) Gets FDA Clearance to Commence PLX-PAD Phase II
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Pluristem Therapeutics, Inc. (Nasdaq: PSTI) reports 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 (150x106 and 300x106) 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 Test. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed.
Pluristem's IC Phase II trial will evaluate the safety and efficacy of two doses (150x106 and 300x106) 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 Test. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed.
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