Pluristem Therapeutics Collaborates With Pharmicell Europe GmbH To Distribute Pluristem’s Cell Therapy Product For Clinical Trials In Germany

February 24, 2009 at 2:00 pm Leave a comment


Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that it has signed a collaboration agreement with Pharmicell Europe GmbH. Under the Agreement, Pharmicell will distribute PLX-PAD, Pluristem’s placental-derived adherent stromal cell product, to various clinical sites in Germany, in connection with Pluristem’s upcoming clinical trials for the indication of Critical Limb Ischemia.




Upon approval of Pluristem’s Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) submissions in the U.S. and Europe, Pluristem plans to initiate Phase I clinical trials by administering PLX-PAD to patients afflicted with critical limb ischemia, who have not responded to traditional medical or surgical interventions. In connection with these planned clinical trials, Pharmicell will distribute PLX-PAD to the clinical sites at Charité-Universitätsmedizin, and Franziskus-Krankenhaus, both located in Berlin.




“PLX-PAD should be stored in a location close to the clinical sites in Berlin, so it could reach the patients in a timely manner when treatment is required,” stated Zami Aberman, Chairman, President and CEO of Pluristem. “Collaborating with Pharmicell gives Pluristem the advantage of storing this ready-to-use cell product under stringent conditions in a German regulated facility prior to dispensing it for patient use,” he added.



About Pharmicell




Pharmicell has extensive experience in manufacturing and banking of sterile cell therapy products in its own state of the art GMP facility. Pharmicell has obtained a license for the manufacture and marketing of adipose derived cells for autologous application in aesthetic and reconstructive surgery. Pharmicell Europe is a subsidiary of South Korea-based FCB Pharmicell Co. Ltd., a leading stem cell company in Korea with on-going clinical trials for the use of autologous bone marrow derived stem cells in myocardial infarction and spinal cord injury.




For more information visit Pharmicell’s website at http://www.pharmicell.eu



About Pluristem




Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (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 adherent stromal cells (ASCs) are expanded in the Company’s proprietary PluriXTM 3D bioreactor, which imitates the natural 3D microenvironment of these cells and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells’ efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess 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-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting Multiple Sclerosis; 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; and PLX-STROKE, targeting ischemic stroke.




Pluristem has offices in the USA with research and manufacturing facilities in Israel.



Safe Harbor Statement




This press release may contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we say that upon approval of our Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) submissions in the U.S. and Europe, we plan to initiate Phase I clinical trials by administering PLX-PAD to patients afflicted with critical limb ischemia who have not responded to traditional medical or surgical interventions, we are using forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risk and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.



Pluristem Therapeutics Inc.

[Via http://www.medicalnewstoday.com]

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