Pluristem Announces Second Clinical Indication Revascularization Effect After PLX-PAD TherapyNEW YORK--(BUSINESS WIRE)--Jan 8, 2008 - Pluristem Therapeutics Inc. (NasdaqCM:PSTI)(DAX:PJT), a leading bio-therapeutics Company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of malignant, ischemic and autoimmune disorders, announced today that it has identified a second clinical indication for its proprietary PLX cells and the expansion of its pipeline of PLX products. Pluristem's PLX-PAD is expected to begin clinical trials in the second half of 2008 in Europe for the treatment of limb ischemia associated with peripheral artery disease (PAD).
Pluristem's Chairman and CEO, Zami Aberman, commented: "The consistent impressive results we are obtaining in our pre-clinical in vivo studies with PLX-PAD suggest this cellular therapy may be the first allogeneic, off-the-shelf product to successfully treat this serious disease." Mr. Aberman added: "We are pleased that PLX-PAD will join PLX-I, our first product used as an alternative to bone marrow transplantation for treating hematological malignancies, in building a meaningful pipeline of PLX products."
Scientists have confirmed that studies in animals whose hind legs were rendered ischemic using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization of the limbs treated with PLX-PAD cells but not in those limbs not treated with PLX-PAD. Additionally, immunohistochemical analyses of those limbs treated with PLX-PAD indicated a significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation).
Pluristem plans to initiate Phase I clinical trials using PLX-PAD in Europe in the second half of 2008 in collaboration with a major clinical research institution. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem's PLX-PAD, as alternative treatments.
About Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with 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.
Pluristem Therapeutics Inc. is a company dedicated to the commercialization of non-personalized (allogeneic) stem cell therapy products for the treatment of numerous severe degenerative, malignant and autoimmune disorders. The Company's first product, PLX-I, is directed at resolving 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 (UCB).
Pluristem's products are derived from mesenchymal stromal cells (MSCs) obtained from the placenta, a non-controversial source, and not from embryonic stem cells. The MSCs are expanded in the Company's proprietary PluriX(TM) 3D bioreactor that imitates the natural microstructure of bone marrow and does not require supplemental growth factors, cytokines or other exogenous materials. Pluristem believes the resultant expanded cells, termed PLX cells, are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to their secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are believed to be immune-privileged and immunosuppressive, hence protecting the recipient from immunological reactions that often accompany transplantation.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
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 other federal securities laws. 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. Forward-looking statements in this release include that PLX cells show promise in treating limb ischemia; that therapeutics used in the treatment of limb ischemia have a potential market of over $1 Billion; that Pluristem's cells can potentially result in beneficial therapies for a number of serious diseases and that the Company's PLX cells may be useful for treating or causing revascularization in the disease of limb ischemia; that these results are encouraging and suggest that our PLX cells may be the first allogeneic, off-the-shelf product to treat this serious disease. Factors that could prevent our forward looking statements from being achieved include that we may be unable to get regulatory approval for our products; we may be unsuccessful in developing any products; 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 to protect essential aspects of our technology; competitors may invent better technology; our products may not work as well as hoped or worse, our products may harm recipients; and we may not be able to raise funds for development or working capital when we require it. In addition, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. 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, including the Company's latest annual report on form 10-KSB.
For more information visit our website at www.pluristem.com, the content of which is not part of this press release.
Posted: January 2008