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news.Pluristem Therapeutics has received approval from an independent data safety monitoring board (DSMB) to advance to the final dose level with its placenta-derived cell therapy product PLX-PAD, in a Phase I dose-escalating clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
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Reportedly, Pluristem is expected to involve 15 adults in the study. The Phase I study is designed to evaluate the safety of PLX-PAD on three dose levels in patients diagnosed with CLI.
Hans-Dieter Volk, head of the immunology advisory board of the study, said: “Satisfactory results from the previous two dose levels and the rapid advancement to the highest dose level is a further indication that PLX-PAD is a safe and potentially efficacious treatment for CLI. At this dose level, we hope to further establish a safety profile for PLX-PAD while continuing to observe the positive trend towards efficacy with a reduction in the Rutherford Category, a gauge of the severity of CLI.”
Zami Aberman, chairman and CEO of Pluristem, said: “We have met another significant milestone with this final dose in the Phase I trial. Trends towards efficacy demonstrated in the lower doses suggest that PLX-PAD cells are a viable source for cell therapy.”