Pluristem Therapeutics Completes Dosing of First Group of Patients in Europe With Placenta-Derived Cell Therapy Product PLX-PAD in Phase I Clinical Trial for Treatment of Critical Limb Ischemia (CLI)
HAIFA, Israel, Dec 1, 2009 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) today announced that it has completed dosing of the first of three dosage groups of patients in Europe with its placenta-derived cell therapy product, PLX-PAD, in a Phase I dose-escalating clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
The three patients treated in this group received the lowest of the three doses in the trial. The Data Safety Monitoring Board (DSMB), an independent board monitoring the safety of PLX-PAD, will meet in approximately 30 days to determine dose escalation to the next dose level to be administered in this trial.
"The successful completion of the first dose group and the positive results from the first patient treated with PLX-PAD may allow us to move rapidly into treatment at the intermediate dose level," said Professor Doctor Andre Schmidt-Lucke, director of the Franziskus-Krankenhaus Institute of Berlin and Project Leader of the PLX-PAD clinical trial in Europe.
Zami Aberman, chairman and CEO of Pluristem, added, "This is a significant milestone for Pluristem as we move forward with our clinical trials in Europe and the U.S."
Pluristem received Clinical Trial Application (CTA) approval to conduct clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 15 adults with the disease will be included in the trial. |
