Pluristem sets June target for phase 2 cell therapy readout

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The biotech had hoped to have data ready for publication early in 2018, but that target came and went. (Zachi Evenor/CC BY 3.0)

Pluristem Therapeutics is planning to publish data from a phase 2 trial of its placenta-derived cell therapy PLX-PAD next month. The data set on patients with intermittent claudication will become the biggest generated by Pluristem to date when it is finalized in the coming weeks. 

Haifa, Israel-based Pluristem’s R&D operation is built upon placenta-derived adherent stromal cells, which the biotech has designed for use in patients of all human leukocyte antigen types. This approach is made possible by the low immunogenicity of the cells. Once inside the body, Pluristem hopes the cells will drive the healing of injured tissue.

The phase 2 trial of 172 patients with intermittent claudication—painful cramps that affect patients with peripheral arterial disease—is the biggest test of the cells to date.     

Pluristem’s timeline for the trial has slipped over the course of the study. The biotech had hoped to have data ready for publication early in 2018 but that target came and went. The cell therapy player reset its sights on the second quarter, a target (PDF) it looks set to hit, but only just.

The size of the trial makes the top-line data a big moment for Pluristem. PLX-PAD has advanced into phase 3 trials in patients with critical limb ischemia or hip fractures over the past year but the clinical data sets that supported this progress were fairly small and raised possible causes for concern. Trials of the cells have featured a clinical hold, deaths and a severe allergic reaction.

Pluristem came through those wobbles to emerge as a late-phase biotech, albeit one that still has big questions to answer about its pipeline prospects.