Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that its PLX cell therapy product, derived from human placenta, a non-controversial, non-embryonic, adult stem cell source, was selected as the only cell therapy product candidate to enter into a study seeking treatments for diastolic heart failure (DHF) in the European Commission’s Seventh Framework Program (FP7). Pluristem is to receive a grant from the FP7 to cover study related R&D expenses. The study will test the effects of PLX (PLacental eXpanded) cells on various heart cell types under high glucose conditions. Uncontrolled high glucose levels in type 2 diabetes patients can lead to oxidative stress in the heart. This condition can cause local inflammation which can result in fibrosis of the heart muscle and the development of diastolic heart failure (DHF). The properties of Pluristem’s PLX cells may prevent or delay the development of this extremely common but devastating disease. "There has been a growing interest in the potential of PLX cells to treat a variety of clinical indications following the release of the PLX-PAD clinical study interim results, which demonstrated safety and shows a trend of efficacy. The decision to use our PLX cells in this DHF study is further verification of the uniqueness of Pluristem’s PLX cells as an off-the-shelf product that requires no tissue matching prior to administration," said Zami Aberman, chairman and CEO of Pluristem. “There is a significant unmet medical need for the treatment of DHF, not only in Europe but also globally, and Pluristem’s placenta-derived cell therapy may provide patients and physicians with an effective and safe treatment option for this disease.” Approximately 15 million people worldwide suffer from DHF with the prevalence increasing as the population ages. Heart failure has now become the leading cause of hospitalization among patients over the age of 65 and it has been estimated that the cost of treating the disease in 2010 will exceed $39 Billion in the U.S. alone.
The Study consortium consists of 19 partners from 12 countries. Its objective is to investigate how metabolic derangements contribute to DHF, how diagnostic algorithms for DHF can be improved by assessing metabolic risk and how the correction of metabolic risk or of metabolic risk-induced cardiac abnormalities can open new therapeutic perspectives for DHF.About Pluristem Pluristem is a clinical stage biotechnology company with patented technology for the development and manufacturing of standardized cell therapies derived from the human placenta. Pluristem’s proprietary and scalable PLX (PLacental eXpanded) cell product candidates are developed as readily available for the treatment of critical limb ischemia (CLI) and other diseases. See our product animation on YouTube: Animation, the content of which is not part of this press release. 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, we are using forward looking statements when we say that Pluristem is to receive grant from the FP7 to cover study related R&D expenses, or that the properties of Pluristem’s PLX cells may prevent or delay the development of DHF, or that the PLX-PAD clinical study interim results demonstrated potential safety and shows a trend of efficacy, or that the decision to use our PLX cells in this DHF study is further verification of the uniqueness of Pluristem’s PLX cells as an off-the-shelf product that requires no tissue matching prior to administration, or that Pluristem’s placenta-derived cell therapy may potentially provide patients and physicians with an effective and safe treatment option for DHF. 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; we may encounter delays or obstacles in launching our clinical trials; 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; our products may wind up being more expensive than we anticipate; 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 risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
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