March 9, 2010: Pluristem Therapeutics Inc has received approval from an independent Data Safety Monitoring Board (DSMB) to advance to the highest and final dose level with its placenta-derived cell therapy product, PLX-PAD, in a Phase 1I dose-escalating clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
“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,” said Professor Doctor Hans-Dieter Volk, chairman of the Institute for Medical Immunology and the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) and the head of the immunology advisory board of the study. “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.”
The Phase 1 study is designed to evaluate the safety of PLX-PAD on three dose levels in patients diagnosed with CLI. A total of up to 15 adults with the disease will be included in this dose-escalating trial.
Pluristem is a clinical-stage biotechnology company with proprietary technology for the development and manufacturing of standardised cell therapies derived from the human placenta. The company’s patented and scalable PLX (Placental eXpanded) cell product candidates are developed as readily available for the treatment of critical limb ischemia (CLI) and other diseases.
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