HAIFA, Israel, July 11, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc . (Nasdaq: PSTI ) (TASE: PLTR ), a leading developer of placenta-based cell therapies, announced today it has completed the target enrollment in a randomized, double-blinded, placebo controlled Phase I/II clinical trial to assess the safety and efficacy of its PLacental Expanded (PLX) cells for the treatment of traumatized muscles. All patients have been treated with PLX-PAD cells or placebo and are currently in the follow up stage of the trial.
The study is being conducted at the Orthopedic Clinic on the campus of the Charité University Medical School in Berlin, Germany and is under the oversight of Germany's healthcare regulatory bodies, the Paul Ehrlich Institute (PEI) and Berlin's Ethic Committee, LaGeSo.
In this trial patients were injected with either PLX-PAD cells or placebo directly into their gluteal muscles that had been surgically traumatized during hip replacement surgery. The primary endpoint of the study is to assess the safety and efficacy of PLX-PAD cells in evaluating the rehabilitation of the muscle activity of the patient at six months following treatment. Secondary efficacy endpoints include Magnetic Resonance Imaging (MRI) and macroscopic and microscopic structure of the involved gluteal muscles from biopsies taken at three months post therapy (Reference: http://clinicaltrials.gov/ct2/show/NCT0152566...tem&rank=3 ).
"Having treated all patients in this trial, we have reached a milestone. The ease of use of our allogeneic, off-the-shelf product enabled us to complete recruitment quickly and efficiently. Following completion of the follow up period, we will obtain data on the safety and efficacy of PLX-PAD cells in the treatment of traumatized muscles during hip replacement surgery" stated Zami Aberman, Chairman and CEO of Pluristem. "This trial is important as it marks the first time PLX-PAD cells have been used in patients following surgically induced muscle trauma. It also provides data on the potential use of PLX cells for the treatment of sports related injuries."
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com , the content of which is not part of this press release.
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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 discuss our Phase I/II muscle injury trial and that we will obtain data on the safety and efficacy of PLX-PAD cells in the treatment of traumatized muscles as well as data on on the potential use of PLX cells for the treatment of sports related injuries, we are using forward-looking statements. These forward-looking statements and their implications 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 and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, 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; results of preclinical studies may not correlate with the results of human clinical trials; 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.
Pluristem Therapeutics Inc.: William Prather R.Ph., M.D. Sr. VP Corporate Development 1-303-883-4954 Daya Lettvin Investor & Media Relations Director +972-54-674-5580
