Pluristem Therapeutics Announces Interim Top-Line Results From PLX-PAD Clinical Trials
Pluristem Therapeutics Inc. announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The interim data demonstrated that PLX-PAD is safe, well tolerated and effective.
A total of twenty-one patients, representing 77% of the cohorts required to complete the Phase I dose-escalating studies in the U.S. and Germany, have been dosed with PLX-PAD. This includes fifteen patients dosed in Germany, representing the complete patient enrollment in that country.
These Phase I studies were designed to evaluate the safety of PLX-PAD in patients with CLI. Both trials have currently met their primary safety endpoints. Additionally, the administration of PLX-PAD cells did not induce an immune response in any of the patients dosed, demonstrating that injection of PLX-PAD cells is well tolerated.
"Comprehensive immunological testing of patients has demonstrated that PLX-PAD cells can be injected in three dose levels without demonstrating serious adverse effects," said Hans-Dieter Volk, Ph.D., professor of immunology and chair of the Institute of Medical Immunology Charité - Universitätsmedizin Berlin and Berlin-Brandenburg Center for Regenerative Therapies (BCRT). "This finding is a further indication that PLX-PAD is well-tolerated and a promising treatment for CLI."
Twelve of the twenty one patients dosed have completed their three-month follow-up. Patient improvement was assessed by analyzing the hemodynamic measurements as defined in the efficacy parameters in the study protocol: the ankle-brachial index (ABI), toe-brachial index (TBI) and transcutaneous oxygen tension (TcPO2). Ten of these twelve patients (83%) demonstrated an improvement in at least one of these parameters, with 95% Confidence Interval (0.55,0.95). In addition, ten of these twelve patients (83%) demonstrated an improvement in their Quality of Life (QoL) with 95% Confidence Interval (0.55,0.95).
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