“Finding a non-surgical medical solution for PAD has proven to be one of the biggest medical challenges in recent years.”
Pluristem Therapeutics, a Haifa- based developer of placenta- based cell therapy products, announced this week that a phase II clinical study of its PLXPAD cells shows positive topline results in the treatment of intermittent claudication (IC).
IC is an early stage of peripheral arterial disease (PAD), which is caused by fatty deposits in leg arteries that obstruct blood flow. PAD – which most often affects people who smoke, have diabetes, are overweight or suffer from hypertension – impacts 4% to 12% of people aged 55 to 70, and 15% to 20% of people aged 70 and older.
IC can progress to critical limb ischemia (insufficient blood supply – CLI) with a high risk of amputation or even death.
“Finding a non-surgical medical solution for PAD, especially in patients who are unsuitable for revascularization has proven to be one of the biggest medical challenges in recent years,” explained Dr. Norbert Weiss, director of the Vascular Center at the Technical University of Dresden, Germany, and the principal investigator for the European Phase II IC study.
“These study results are highly encouraging.”
According to Pluristem Therapeutics, patients treated with an optimal two doses of 300 million PLX-PAD cells over 52 weeks show reduced risk of revascularization (49%) – the need to restore circulation to a body part or organ that has suffered ischemia – and increased mobility.
The study, which took place at 28 clinical sites in the United States, Germany, South Korea and Israel, and involved 172 patients in four randomized categories, likewise validates the design of Pluristem’s ongoing pivotal phase III clinical study in CLI. The study showed that Pluristem’s proprietary bio-therapeutic approach of using cells originating from different placentas for each individual treatment generates a superior therapeutic effect.
Pluristem chairman and co-CEO Zami Aberman said the results should bring hope to millions of patients worldwide suffering from PAD.