PluristemTherapeutics Announces First Patient Enrollment in Phase I Clinical Trial for Treatment of Peripheral Artery Disease With PLX-PAD

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Tue Jul 7, 2009 4:00am EDT

HAIFA, Israel--(Business Wire)--
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics
company dedicated to the commercialization of unrelated donor-patient
(allogeneic) cell therapy products for a variety of disorders, announced today
that the first patient has been enrolled in a Phase I clinical trial of the
Company`s allogeneic placental-derived adherent stromal cell product, termed
PLX-PAD. PLX-PAD is being used in patients afflicted with critical limb ischemia
(CLI), the end-stage of peripheral artery disease (PAD). The first patient was
enrolled at the Franziskus-Krankenhaus Hospital, Berlin. The initiation of this
study follows the recent approval of the Company`s Clinical Trial Application
(CTA) to begin clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI),
the German competent authority in the European Union. The Phase I study is
designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up
to fifteen adults with the disease will be included in the trial which is being
conducted at the Franziskus-Krankenhaus Hospital and Charité -
Universitätsmedizin Hospital, Berlin. 

Zami Aberman, Chairman, President and CEO of Pluristem stated, "We are proud to
begin clinical trials with PLX-PAD, a cellular therapeutic product derived from
the placenta, the organ intimately involved in the miracle of birth and a
ubiquitous source of adult stromal cells that are easily obtained without harm
to the mother or baby. Additionally, our proprietary three-dimensional mass
manufacturing technology allows us to grow cells significantly more efficiently
and cost-effectively than cells grown via the labor intensive two-dimensional
method which is the industry norm." 

About Pluristem

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the
commercialization of unrelated donor-patient (allogeneic) cell therapy products
for the treatment of several severe degenerative, ischemic and autoimmune
disorders. Pluristem's first product, PLX-PAD (for the treatment of Peripheral
Artery Disease), a "First-In-Human" placental-derived mesenchymanl-like stromal
cell product, has received FDA and IMPD clearance and is being investigated in a
Phase I clinical trial. The Company is developing a pipeline of products derived
from human placenta, a non-controversial, non-embryonic, adult stem cell source.
The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use,
and require no histocompatibility matching. 

These placental adherent stromal cells (ASCs) are expanded in the Company's
proprietary PluriXTM 3D bioreactor system, which provides a 3D microenvironment
that enables large-scale growth of these cells without the need for supplemental
growth factors or other exogenous materials. PLX cells are immune privileged,
possess immunomodulatory properties, and are expanded in vitro without showing
signs of phenotypic or karyotypic changes. Pluristem believes that the PLX
cells` mechanism of action may be related to the secretion of cytokines and/or
other potent immune modulators. 

The Company's additional product candidates include PLX-IBD, targeting
Inflammatory Bowel Disease, which includes Crohn`s disease and Ulcerative
Colitis; PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global
shortfall of matched tissue for bone marrow transplantation by improving the
engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord
blood; and PLX-STROKE, targeting ischemic stroke. 

Pluristem has offices in the USA with research and manufacturing facilities in
Israel. 

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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 we discuss our proprietary
three-dimension manufacturing technology and its advantage over a two-dimension
method, 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. 





Pluristem Therapeutics Inc.
William Prather RPh, MD, +1-303-883-4954
Sr. VP Corporate Development
William.PratherMD@pluristem.com



Copyright Business Wire 2009

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