HAIFA, Israel, Dec. 1, 2009 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) today announced that it has completed dosing of the first of three dosage groups of patients in Europe with its placenta-derived cell therapy product, PLX-PAD, in a Phase I dose-escalating clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
The three patients treated in this group received the lowest of the three doses in the trial. The Data Safety Monitoring Board (DSMB), an independent board monitoring the safety of PLX-PAD, will meet in approximately 30 days to determine dose escalation to the next dose level to be administered in this trial.
"The successful completion of the first dose group and the positive results from the first patient treated with PLX-PAD may allow us to move rapidly into treatment at the intermediate dose level," said Professor Doctor Andre Schmidt-Lucke, director of the Franziskus-Krankenhaus Institute of Berlin and Project Leader of the PLX-PAD clinical trial in Europe.
Zami Aberman, chairman and CEO of Pluristem, added, "This is a significant milestone for Pluristem as we move forward with our clinical trials in Europe and the U.S."
Pluristem received Clinical Trial Application (CTA) approval to conduct clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 15 adults with the disease will be included in the 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.
See our product animation on YouTube: Animation, the content of which is not part of this press release.
The Pluristem Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6882
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 successful completion of the first dose group and the positive results from the first patient treated with PLX-PAD may allow us to move rapidly into treatment at the intermediate dose level, or that this is a significant milestone for Pluristem as we move forward with our clinical trials in Europe and the U.S., or that a total of up to 15 adults with CLI will be included in the clinical trial, 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 website at www.pluristem.com, the content of which is not part of this press release.