Ramping up !!!
Pluristem Certified as a Good Manufacturing Practices (GMP) Site for the Manufacture of PLX cells for its Clinical Trials
BUSINESS WIRE
Posted: 2008-06-25 10:09:56
NEW YORK--(BUSINESS WIRE)----Pluristem Therapeutics Inc. (NASDAQ:PSTI); (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, today announced that the Company has received certification that its manufacturing facility in Haifa, Israel has been approved as a Good Manufacturing Practices (GMP) standard 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(TM) 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 begin Phase I/II clinical trials for our first product, PLX-PAD for the treatment of patients with peripheral artery disease (PAD), during Q4 of this year."
About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental mesenchymal stromal cells (MSCs) are expanded in the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's products in development also include PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; PLX-STROKE, targeting ischemic stroke; PLX-MS, targeting Multiple Sclerosis; and PLX-IBD, targeting Inflammatory Bowel Disease (IBD), which includes Crohn's disease and Ulcerative Colitis.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
See our product animation on YouTube:
youtube.com. |
