Israel's Pluristem Therapeutics Inc. said a mid-stage trial of its cell therapy PLX-PAD improved mobility in patients with a type of artery disease.
The biotherapeutics company was studying the therapy in 172 patients with intermittent claudication from U.S., Germany, South Korea and Israel.
Intermittent claudication is a condition that causes aches or pain in the legs due to poor circulation of blood in the arteries of the legs. It typically occurs with walking and goes away with rest.
The condition can progress to critical limb ischemia, which occurs when severely obstructed arteries cause reduced blood flow to the limbs.
In the phase 2 study, PLX-PAD was found to have improved patients' maximal walking distance from baseline after 52 weeks. It was also found to be better than placebo in treating the condition.
The study also showed that the therapy reduced the risk of revascularization by 49% in the main efficacy group of patients that received two administrations of 300 million PLX-PAD cells three months apart. Revascularization occurs when blood flow is restored to a body part or organ that has suffered ischemia.
Pluristem continues to study the treatment in a phase 3 trial of patients with critical limb ischemia, an advanced stage of the peripheral arterial disease that affects 20 million U.S. citizens, 28 million Western Europeans and 42 million to 60 million Chinese citizens.
