Pluristem Certified as a Good Manufacturing Practices Site for the Manufacture of PLX cells for its Clinical Trials
News Jun 26, 2008
Pluristem Therapeutics Inc. has announced that the Company has received certification that its manufacturing facility in Haifa, Israel has been approved as a Good Manufacturing Practices (GMP) site for the purpose of manufacturing PLX cells which will be shipped to the EU for use in the Company’s upcoming clinical trials.
Pluristem was awarded this certification by Biotec Distribution Wales, Ltd., the designee of the Paul Ehrlich Institute, the EU equivalent to the FDA, to monitor the import, certification, labeling, storage and distribution of PLX cells into the EU for clinical trials. PLX cells are Pluristem’s placental-derived mesenchymal stromal cells (MSCs) that have been expanded in the Company’s proprietary PluriX™ 3-D bioreactor.
Mr. Zami Aberman, Pluristem's President & CEO, stated: "Obtaining GMP approval to manufacture our PLX cells for shipment into the EU is a major step towards launching our clinical trials in Europe. Our target is to start Phase I/II clinical trials during Q4 of this year for our first product, PLX-PAD, for the treatment of patients with peripheral artery disease (PAD)".