Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that following its meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP), the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (CLI) and Moderate-severe Claudication. The company has also received approval for a government grant in the amount of $2.5 million from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of Israel, as government participation in R&D expenses for the period March 2010 to February 2011. This is the fifth consecutive year that Pluristem has received this grant. Two Phase IIb studies will further evaluate the safety and efficacy of PLX-PAD in patients suffering from CLI, the end stage of peripheral artery disease (PAD), and Moderate-severe Claudication. In the U.S., there is a significant unmet medical need for an effective and economical treatment for both conditions, which have an estimated national cost of $14.3 billion annually, based on inpatient hospital bills. “The rapid advancement of PLX-PAD through clinical trials may allow us to bring to the market a cost-effective treatment for CLI and Moderate-severe Claudication as well as to help relieve the large economic burden currently sustained in treating these disorders,” said Zami Aberman, Pluristem’s chairman and CEO. “Additionally, we are pleased yet again to receive the prestigious Israeli government award to support our novel drug delivery therapy. We will use this grant to accelerate the progress toward our Phase IIb clinical trials.” About PAD Approximately 12 million people in the U.S. suffer from limb ischemia associated with PAD. The economic impact of this growing burden of patients afflicted with PAD is being experienced acutely in the United States with approximately $14.3 billion annually in national inpatient bills for the treatment of PAD and $10.2 billion annually in national inpatient bills for the treatment of CLI. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led to the medical community’s call for the development of cell therapies, such as Pluristem’s PLX-PAD, as alternative and potentially cost-effective treatments.
About PluristemPluristem 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. In April 2010, Pluristem reported interim top-line results from Phase I clinical trials of PLX-PAD that demonstrated the cell therapy is potentially safe, well tolerated and effective in patients with critical limb ischemia (CLI). 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, when we say that the rapid advancement of PLX-PAD through clinical trials may allow us to bring to the market a cost-effective treatment for CLI and Moderate-severe Claudication as well as to help relieve the large economic burden currently sustained in treating these disorders, or that we will use the Israeli government grant to accelerate the progress towards our Phase IIb clinical trials, 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; 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. For more information visit our Web site at www.pluristem.com, the content of which is not part of this press release.