TEL AVIV (Reuters)
Israel’s Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said on Tuesday it had positive results from a mid-stage study of its therapy to treat leg pain known as intermittent claudication (IC)
Pluristem said its PLX-PAD treatment reduced incidence of revascularization and improved patients’ mobility.
IC – muscle pain and weakness brought on by exercise – is usually associated with early-stage peripheral artery disease and if not treated can progress to critical limb ischemia (CLI), where patients are at risk of leg amputation and death.
The Phase II study was designed to evaluate the safety, efficacy and optimal dosing regimen for PLX-PAD cells in patients with IC. Enrollment took place at 28 clinical sites in the United States, Germany, South Korea and Israel.
The study’s results also validate the design of Pluristem’s advanced Phase III trial for CLI, the company said.
(Reporting by Tova Cohen, Editing by Ari Rabinovitch)