Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

Apr 27 2010

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) today 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)

"The majority of the patients treated reported an improvement in their quality of life and objective efficacy parameters," said Professor Doctor André Schmidt-Lucke, director of the Franziskus-Krankenhaus Institute of Berlin, Germany, and the leading study physician of the German trial. "We are encouraged by the results of this safety study and the potential for PLX-PAD as a treatment for CLI."

Zami Aberman, chairman and CEO of Pluristem, added, "The interim results of this study have demonstrated that PLX-PAD cells can be administered without evoking the patient's immune response and that the majority of the patients benefited from the PLX-PAD therapy. We plan to continue with the clinical development of PLX-PAD and the advancement to Phase II studies."