Pluristem has announced its pivotal Phase III clinical trial to treat critical limb ischemia received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the coming months.
Pluristem’s PLX-PAD cells will be evaluated in a double blind, randomized, placebo controlled trial in 250 patients.
The global market for treating critical limb ischemia is $12 billion globally. 1.7 million patients who live in world’s largest and most advanced pharmaceutical markets suffer from this limb-threatening and life-threatening disease. This number is expected to top 2 million in the next five years.
Pluristem’s critical limb ischemia program has been selected by the European Medicines Agency for its Adaptive Pathways pilot project. This allows for faster marketing approval in Europe after a single pivotal Phase III trial.
In the current Phase III trial, an interim analysis of data will be made for the first 125 patients, potentially leading to early marketing approval in Europe. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S.
Regenerative medicines like PLX cells will have tremendous benefits on healthcare economics based on their efficacy and their non-invasive nature.