Pluristem Initiates Final Validation of New Manufacturing Facility
December 27 2012 - 2:00AM
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today it has
initiated the final validation steps for its new "state-of-the-art"
manufacturing facility prior to taking possession of the facility.
These steps include the validation of several installation systems
including as heating, ventilation and air conditioning (HVAC),
water, oil free air and sterile room systems.
Zami Aberman, Chairman and CEO of Pluristem commented, "I am
extremely proud of our team in meeting milestones for the
completion of the world's first commercial cell therapy
manufacturing facility. Assuming the PLX cells product candidates
are successfully developed and approved by the regulators, we
believe that the new facility would have the capacity to produce
PLX cells for the treatment of over 150,000 patients annually
estimated by Pluristem at $1 billion in production value.
Additionally, as clinical trials are approved by regulators for
additional indications, our new facility will enable us to supply
PLX cells to conduct these trials in parallel."
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.
The Pluristem Therapeutics Inc. logo is available a
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 discuss our new manufacturing facility,
its validation process, its planned capacity for production of PLX
cells and estimated production value assuming the PLX cells product
candidates are successfully developed and approved by the
regulators, or when we say that as clinical trials are approved by
regulators for additional indications, our new facility will enable
us to supply PLX cells to conduct these trials in parallel, 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 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.
CONTACT: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
1-303-883-4954
William.PratherMD@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com