Haifa, Israel — Pluristem Therapeutics Inc has announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the FDA regarding the Company’s planned clinical development program for PLX-PAD.
Based on positive feedback from the EMA and FDA, Pluristem feels that it is now in a position to advance towards two clinical studies with its PLX-PAD cells: a joint FDA-EMA Phase II/III study of PLX-PAD for critical limb ischemia (CLI) and a Phase II study for intermittent claudication (IC) under the FDA and the Paul Ehrlich Institute (PEI), the German competent authority in the European Union.
"PLX-PAD has shown promise throughout its initial clinical development, and I am pleased that both the EMA and FDA have acknowledged our proposed comprehensive clinical development plan, which may lead to an advanced cell therapy product that could help millions of PAD patients," said Zami Aberman, chairman and CEO of Pluristem. "The completion of two Phase-I CLI clinical studies, performed in parallel in Germany and the US, placed Pluristem in a unique position to discuss with the regulatory agencies an approach that should allow a single clinical study protocol to be accepted by both agencies,"
The EMA and FDA concurred on the main protocol design elements. The Phase II/III clinical trial will be a multinational, multicenter, randomized, double-blind, placebo control, parallel study. Patients with CLI, Fontaine class III-IV, Rutherford category 4-5, will be enrolled and treated with two PLX-PAD treatments or with two placebo treatments, a few months apart. PLX-PAD or placebo will be administered via multi-intramuscular injections delivered to the affected leg.
The primary endpoint of the study will be major-amputation free survival rate (amputations and death) at 12 months from the initial treatment with PLX-PAD or placebo.
SOURCE: Pluristem Therapeutics Inc
