PluristemBegins Enrollment in U.S. With Unmatched Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease

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Thu Sep 10, 2009 9:00am EDT

HAIFA, Israel--(Business Wire)--
Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it
has begun enrolling patients in the U.S. for a Phase I clinical trial with its
unmatched placenta-derived stem cell product, PLX-PAD, the Company`s leading
product candidate for the treatment of critical limb ischemia (CLI), the
end-stage of peripheral artery disease (PAD). 

Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala.,
one of two clinical sites in the U.S. Duke University Medical Center will also
be screening patients for the trial. The initiation of this study follows the
approval of the Company`s Investigational New Drug (IND) application to begin
clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The
Phase I study is designed to evaluate the safety of PLX-PAD in patients with
CLI. A total of up to 12 adults with the disease will be included in this dose
escalating trial. 

"Initiation of the clinical trial in the U.S. with our unmatched
placenta-derived stem cell therapy product signifies another major milestone for
Pluristem," said Zami Aberman, chairman, president and CEO of Pluristem. "This
significant development, together with the beginning of dosing in Europe in July
of this year, demonstrates our commitment to advancing our product pipeline and
our strong position in the stem cell space." 

About Pluristem

Pluristem Therapeutics Inc. is a clinical development 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
mesenchymal-like stromal cell product, has received both the FDA and Paul Erlich
Institute (PEI) clearance and is being investigated in Phase I clinical trials.
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. 

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. 

See our product animation on YouTube: Animation, the content of which is not
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 say that the initiation of the
clinical trial in the U.S. with our unmatched placenta-derived stem cell therapy
signifies another major milestone for us, or that this development, together
with the beginning of dosing in Europe in July of this year, demonstrates our
commitment to advancing our product pipeline and our strong position in the stem
cell space, or when we discuss the number of adults that will be included in
this dose escalating trial, 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
or
Russo Partners
Andreas Marathovouniotis, +1-212-845-4235
andreas.marathis@russopartnersllc.com

Copyright Business Wire 2009

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