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HAIFA, Israel, Jan. 23, 2014 (GLOBE NEWSWIRE) --
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell product candidates, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), Germany's health authority, to supply cells from its advanced, fully automated, and proprietary 3D cell expansion manufacturing platform implemented at its new state-of-the-art GMP facility. Pluristem's new manufacturing facility has the capability to efficiently produce over 150,000 doses of PLX cells annually, which potentially translates into significant economic value.
This marks the first regulatory approval of Pluristem's new facility where the company has implemented its large scale 3D bioreactor expansion of placental-derived mesenchymal-like Adherent Stromal Cells (ASCs). The approval will enable the company to easily support ongoing trials and enter into multiple clinical trials using its scale-up capabilities for cell supply. The company is also in the process of getting approvals from other regulatory authorities including the US FDA.
"We are very pleased to receive the PEI's approval. Following our multi-million dollar investment into the development of our proprietary high-throughput culturing technologies, 3D bioreactors, and proprietary downstream equipment, the PEI's approval confirms Pluristem's unique position in the cell therapy industry. Our proprietary 3D manufacturing process can create commercial quantities of cells with batch-to-batch consistency, so we are ready to expand and accelerate our clinical programs," stated Zami Aberman, Chairman and CEO of Pluristem. "In addition, the very encouraging results of our Phase I/II trial in muscle injury conducted in Germany suggest that our unique culturing technology may contribute to the quality and consistency of PLX clinical studies."
About Pluristem's 3D Manufacturing Pluristem's state-of-the-art manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and therefore invests major efforts in developing highly efficient, cutting-edge culturing systems enabling advancement of its large PLX cell therapy product candidate's pipeline.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.