Published on December 15, 2009 at 11:47 PM
Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that the independent DSMB approved the advancement to the intermediate dose level of the company’s placenta derived cell therapy, PLX-PAD, in the Phase I clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end stage of peripheral artery disease (PAD).
"The advancement to the next dose level with Pluristem’s placenta derived PLX-PAD is encouraging and we hope that the positive trend in clinical results derived from treating the first patients at the lower dose will continue,” said Professor Dr. André Schmidt-Lucke, director of the Franziskus-Krankenhaus of Berlin and Project Leader of the PLX-PAD clinical trial in Europe.
Zami Aberman, chairman and CEO of Pluristem, added, "The DSMB approval confirms the safety profile of the first dose of PLX-PAD. We hope that the administration of the intermediate dose level will provide further evidence that PLX-PAD is potentially a safe and effective treatment option for patients with CLI.”
This Phase I 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.
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