Pluristem Therapeutics has good reasons to celebrate: its PLX cell program in critical limb ischemia is taking the fast line to the market. The program is the first to have been selected for the European Medicines Agency’s Adaptive Pathways pilot project, which aims at accelerating the access for patients to new medicines.
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. After a therapy is selected for the program, the Adaptive Pathway’s group begins intensive discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.
However, the Adaptive Pathway doesn’t guarantee the success of the PLX cell program. Nevertheless the possibility of an early approval represents a tremendous milestone for Pluristem, as Zami Aberman, the company’s CEO stated.
The company relies on its proprietary PLX cell program to achieve its long-term strategy to lead the cell therapy industry. The technology is based on a cell therapy product which can be defined as mesenchymal-like adherent stromal cells derived from full term human placentas. The company’s unique bioreactor systems that create a three-dimensional microenvironment, allows the production of different PLX cell products for different targeted indications.
For the moment, however, the company will focus on the Critical limb ischemia clinical trials, which Phase II is still at a design stage.