HAIFA, Israel, March 2, 2010 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) today announced that it has received approval from an independent Data Safety Monitoring Board (DSMB) to advance to the highest and final dose level with its placenta-derived cell therapy product, PLX-PAD, in a Phase I dose-escalating clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
"Satisfactory results from the previous two dose levels and the rapid advancement to the highest dose level is a further indication that PLX-PAD is a safe and potentially efficacious treatment for CLI," said Professor Doctor Hans-Dieter Volk, chairman of the Institute for Medical Immunology and the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) and the head of the immunology advisory board of the study. "At this dose level, we hope to further establish a safety profile for PLX-PAD while continuing to observe the positive trend towards efficacy with a reduction in the Rutherford Category, a gauge of the severity of CLI."
Zami Aberman, chairman and CEO of Pluristem, added, "We have met another significant milestone with this final dose in the Phase I trial. Trends towards efficacy demonstrated in the lower doses suggest that PLX-PAD cells are a viable source for cell therapy."
This Phase I study is designed to evaluate the safety of PLX-PAD on three dose levels in patients diagnosed with CLI. A total of up to 15 adults with the disease will be included in this dose escalating trial.
About Pluristem
Pluristem is a clinical stage biotechnology company with proprietary technology for the development and manufacturing of standardized cell therapies derived from the human placenta. Pluristem's patented and scalable PLX (PLacental eXpanded) cell product candidates are developed as readily available for the treatment of critical limb ischemia (CLI) and other diseases.
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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 PLX-PAD is a safe and potentially efficacious treatment for CLI and that PLX-PAD is viable source for cell therapy, 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.
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