Pluristem Therapeutics Announces Interim Top-Line Results From PLX--PAD Clinical Trials
Data Demonstrates PLX-PAD is Safe and Effective
HAIFA, Israel, Apr 27, 2010 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics Inc. /quotes/comstock/15*!psti/quotes/nls/psti (PSTI 1.34, +0.02, +1.52%) (DAX:PJT) today announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The interim data demonstrated that PLX-PAD is safe, well tolerated and effective.
A total of twenty-one patients, representing 77% of the cohorts required to complete the Phase I dose-escalating studies in the U.S. and Germany, have been dosed with PLX-PAD. This includes fifteen patients dosed in Germany, representing the complete patient enrollment in that country.
These Phase I studies were designed to evaluate the safety of PLX-PAD in patients with CLI. Both trials have currently met their primary safety endpoints. Additionally, the administration of PLX-PAD cells did not induce an immune response in any of the patients dosed, demonstrating that injection of PLX-PAD cells is well tolerated.
"Comprehensive immunological testing of patients has demonstrated that PLX-PAD cells can be injected in three dose levels without demonstrating serious adverse effects," said Hans-Dieter Volk, Ph.D., professor of immunology and chair of the Institute of Medical Immunology Charite - Universitätsmedizin Berlin and Berlin-Brandenburg Center for Regenerative Therapies (BCRT). "This finding is a further indication that PLX-PAD is well-tolerated and a promising treatment for CLI."
Twelve of the twenty one patients dosed have completed their three-month follow-up. Patient improvement was assessed by analyzing the hemodynamic measurements as defined in the efficacy parameters in the study protocol: the ankle-brachial index (ABI), toe-brachial index (TBI) and transcutaneous oxygen tension (TcPO2). Ten of these twelve patients (83%) demonstrated an improvement in at least one of these parameters, with 95% Confidence Interval (0.55,0.95). In addition, ten of these twelve patients (83%) demonstrated an improvement in their Quality of Life (QoL) with 95% Confidence Interval (0.55,0.95)
"The majority of the patients treated reported an improvement in their quality of life and objective efficacy parameters," said Professor Doctor Andre Schmidt-Lucke, director of the Franziskus-Krankenhaus Institute of Berlin, Germany, and the leading study physician of the German trial. "We are encouraged by the results of this safety study and the potential for PLX-PAD as a treatment for CLI."
Zami Aberman, chairman and CEO of Pluristem, added, "The interim results of this study have demonstrated that PLX-PAD cells can be administered without evoking the patient's immune response and that the majority of the patients benefited from the PLX-PAD therapy. We plan to continue with the clinical development of PLX-PAD and the advancement to Phase II studies."
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 data demonstrated that PLX-PAD is a safe, well tolerated and effective treatment for PAD; that PLX-PAD cells can be injected in three dose levels without demonstrating serious adverse effects; that the majority of the patients benefited from the PLX-PAD therapy; or that we plan to continue with the clinical development of PLX-PAD and the advancement to Phase II studies, 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.