Pluristem Therapeutics Announces Three Month Follow-Up Data from the First Patient to Receive PLX-PAD
Data Suggests PLX-PAD is Safe, with Noted Improvement in Measured Efficacy Parameters
HAIFA, Israel--(BUSINESS WIRE)--Nov 17, 2009 - Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) today announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company's leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
The first patient was treated with the lowest of three doses and has completed the three month follow up with the following results:
In addition, the patient's VascuQol score (quality of life score), VAS score (pain score), and the hemodynamic parameters, ankle-brachial index, toe-brachial index, and transcutaneous oxygen pressure, improved compared to baseline.
Based on the decrease in the patient's Rutherford Category, Pluristem believes that the patient may no longer fulfill the criteria for the diagnosis of critical limb ischemia.
Professor Doctor André Schmidt-Lucke, Director of the Franziskus-Krankenhaus Institute of Berlin, Germany and Project Leader of the PLX-PAD clinical trial stated, “Although we are early in the clinical trial, Pluristem's PLX-PAD product could represent a significant advancement towards finding an efficacious therapy for critical limb ischemia.”
“These results are the first indication of the safety and efficacy of the treatment with PLX-PAD,” said Zami Aberman, chairman and CEO of Pluristem. “Although these results may not be entirely reproducible in other patients, we are encouraged that the first patient ever to receive our PLX-PAD cells in the lowest of the three doses has exhibited data to suggest our product candidate is safe and potentially efficacious.”
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.
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 say that we believe that the PLX-PAD therapy is safe and potentially efficacious, or that based on the decrease in the patient's Rutherford Category, the patient may no longer fulfill the criteria for the diagnose of critical limb ischemia, or that PLX-PAD product could represent a significant advancement towards finding an efficacious therapy for critical limb ischemia, 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.
Contact: Pluristem Therapeutics Inc.
William Prather RPh, MD, +1-303-883-4954
Sr. VP Corporate Development
Andreas Marathovouniotis, +1-212-845-4235
Posted: November 2009