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news.Pluristem Therapeutics has filed a pre-investigational new drug application with the Paul Ehrlich Institute or PEI in Germany for PLX-PAD, the company's product for the treatment of peripheral artery disease.
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Pluristem has submitted a scientific package to the PEI. The package contains the results of a proof of concept study and preclinical study synopses utilizing PLX-PAD to support an IMPD (investigational medicinal product dossier) submission planned for later this year. This Pre-IND document also contains information concerning the process used to manufacture Pluristem’s PLX-PAD product and the proposed clinical trial supporting the company’s IMPD.
The PEI is the German federal authority granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX technology.