HAIFA, Israel, Jan. 30, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the company has taken possession of and is moving into its new state-of-the-art GMP facility. The facility allows for the production of mass quantities of PLacental eXpanded (PLX) cells that possess the advantages of being grown utilizing Pluristem's patented 3D bioreactor technology.
The new manufacturing facility will have the capability to produce different PLX product candidates with the potential capacity of over 150,000 doses annually. Additionally, if more indications are approved by regulators for clinical trials, this new facility will enable us to supply PLX cells to conduct these additional trials in parallel.
Zami Aberman, Chairman and CEO of Pluristem commented, "We are excited to begin work in our new plant. With this new manufacturing facility, our company is capable of combining the ideal characteristics of a supply source in the placenta with a proprietary expansion technology that successfully addresses the issues of reproducibility and cost to provide high numbers of reproducible batches of the highest quality PLX cells. Our new facility allows increasing the yield from one placenta to over ten times the yield from our previous pilot facility, and puts us in a very strong competitive position compared to traditional two-dimensional expansion technologies."
"Pluristem is developing PLX cell therapies that have shown safety and potential efficacy for a range of indications in our pre-clinical and clinical studies, and now we also have the technology and capabilities to make these treatments, if fully developed and approved by the regulators, available on a large-scale," Aberman added.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) 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 is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.
Pluristem has a strong patent and patent applications portfolio, 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, we are using forward-looking statements when we discuss our new manufacturing facility, its production capacity, its capability to produce different PLX products and increased yield from one placenta that it allows, when we discuss our competitive advantage, or when we discuss our capabilities to make cell treatments, if fully developed and approved by the regulators, available on a large-scale. 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 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.