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news.Pluristem Therapeutics has filed an investigational new drug application with the FDA to begin clinical trials with its placental-derived stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia.
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Following clearance of the investigational new drug (IND) application by the FDA, Pluristem will initiate Phase I dose ranging clinical trials during the first half of 2009 at two clinical sites in the US.
As in the clinical trials with PLX-PAD that are to begin in Europe, the patients in the US trials will be considered ‘late stage’ and defined as patients whose limb ischemia has not responded to traditional medical or surgical interventions and are facing amputation.
Zami Aberman, president and CEO of Pluristem, said: “We are pleased to be filing this IND application in the US. Following approval by the FDA, we will begin administering PLX-PAD to patients afflicted with critical limb ischemia with the goal of proving this product safe.
“The IND application filed with the FDA and the investigational medicinal product dossier application filed in Europe are two important steps in Pluristem’s global strategy to become a dominant player in the cellular therapeutic business arena.”