Health & Fitness
Health and Fitness
Health and Fitness
Mon, December 1, 2008 Pluristem Retains KKS as Its CRO for Upcoming Limb Ischemia Clinical Trial
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 signed an agreement with KKS, retaining them as the Contract Research Organization (CRO) for its upcoming Critical Limb Ischemia (CLI) multi center clinical trial utilizing Pluristem's placental-derived adherent stromal cell product, PLX-PAD.
KKS Charité (Koordinierungszentrum für Klinische Studien der Charité) is the CRO of the Charité (Charité – Universitätsmedizin Berlin) and conducts all clinical trials for this distinguished institution. KKS personnel have vast experience in clinical trial management, including data management, biostatistics, medical writing and regulatory affairs for Phase I to IV trials. In addition, KKS has working relations with the Paul-Ehrlich-Institut (PEI), the German competent authority reporting to the German Federal Ministry of Health, which approves clinical trials and marketing authorizations for biological medicinal products.
KKS will oversee the entire operation and data management of Pluristem's dose escalation, Phase I clinical trial, assessing the safety of PLX-PAD in patients with CLI, at two separate sites in Germany.
Mr. Zami Aberman, Pluristem's President & CEO, stated: "Contracting KKS as Pluristem's CRO for this Phase I Critical Limb Ischemia multi-center clinical trial is yet another important step towards this first-in-man trial, using our off-the-shelf PLX-PAD product that needs no matching, that is to begin in the first half of 2009."
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with peripheral artery diseases (PAD). The disease is characterized by narrowing and hardening of the arteries in the patient's limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications.
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 adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriXTM 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) cell's 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-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.
See our product animation on YouTube: [ http://www.youtube.com/watch?v=OFhWXyJT6Us ]
Safe Harbor Statement
This press release contains 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 the first-in-man trial, using our off-the-shelf PLX-PAD product that needs no matching, is to begin in the first half of 2009", 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.
For more information visit our website at [ www.pluristem.com ], the content of which is not part of this press release.
