NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non- personalized (allogeneic), off-the-shelf, cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that it has filed an Investigational Medicinal Product Dossier (IMPD) application with the Paul Ehrlich Institute (PEI), the German competent authority in the European Union (EU), to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI). Assuming approval of the IMPD by this authority, Pluristem plans to initiate the dose ranging clinical trial during the second quarter of 2009 at two sites in Berlin, Germany. The patient population for this initial clinical trial will be considered "late stage", defined as patients whose limb ischemia has not responded to traditional medical or surgical interventions and are facing amputation. Pluristem also plans to file shortly an Investigational New Drug (IND) application with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), for a similar trial to take place in two US clinical centers.
