Gil Roth11.13.13
Pluristem Therapeutics has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).
The IND approved by the MFDS mirrors INDs already approved by regulators in the U.S., Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co., Ltd., Pluristem's South Korean partner, will fund the trial and conduct it in its healthcare facilities.
The Phase II study of IC is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two courses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol targets enrollment of 150 patients with IC: Fontaine class IIb, Rutherford category 2-3. The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
The IND approved by the MFDS mirrors INDs already approved by regulators in the U.S., Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co., Ltd., Pluristem's South Korean partner, will fund the trial and conduct it in its healthcare facilities.
The Phase II study of IC is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two courses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol targets enrollment of 150 patients with IC: Fontaine class IIb, Rutherford category 2-3. The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.