Monday, April 14, 2008

[StemCells] Pluristem's MSCs = MS improvement, statistically

Pluristem's PLX Cells Show a Statistically Significant Advantage in a
Pre-Clinical Study in the Multiple Sclerosis Model
Posted : Mon, 14 Apr 2008 14:24:53 GMT

NEW YORK - (Business Wire) Pluristem Therapeutics Inc. (NASDAQ:PSTI)
(DAX:PJT) a bio-therapeutics company dedicated to the
commercialization of non-personalized (allogeneic) cell therapy
products for a variety of degenerative, ischemic and autoimmune
indications, announced today that a preclinical study utilizing the
Company's PLacental eXpanded (PLX) cells showed a statistically
significant advantage in ameliorating functional deficiencies in a
standard Multiple Sclerosis (MS) animal model. PLX cells are
mesenchymal stromal cells (MSCs) obtained from the placenta and
expanded using Pluristem's proprietary 3D PluriX™ technology.

Researchers at Pluristem utilized the Experimental Autoimmune
Encephalitis (EAE) animal model for the study, the paradigm for MS in
humans. After EAE was induced, a number of the animals were given PLX
cells intravenously while the remaining served as a control. There
was a significant reduction in the EAE score in those animals given
PLX cells versus the control group and this beneficial effect was
seen throughout the 25-day duration of the study. The EAE score is a
measurement of functional outcomes in the EAE-afflicted animal and
correlates closely with a histological improvement in EAE-induced
lesions. Additionally, the beneficial effects were similar to when
Zappia et. al. used MSCs that were non-placental in origin in this
EAE animal model†.

Zami Aberman, Pluristem's President and CEO said: "We are very
excited that our PLX cells were able to demonstrate beneficial
results that are statistically significant in this standardized model
for Multiple Sclerosis. These results, in addition to our previously
announced PLX STROKE results, demonstrate that PLX cells may be
useful in the treatment of central nervous system (CNS) disorders and
potentially help millions of people. Additionally, we believe this
experiment demonstrates we can potentially utilize our off-the-shelf,
easy to obtain PLX cells and achieve results that are as good as or
better than MSCs obtained from other more difficult to find sources."

†Zappia et. al. Mesenchymal stem cells ameliorate experimental
autoimmune encephalitis inducing T cell anergy. Blood. 2005;106: 1755-
1761

About Multiple Sclerosis (MS)

Multiple sclerosis (MS), also known as disseminated sclerosis or
encephalomyelitis disseminate, is an autoimmune condition in which
the immune system attacks the central nervous system (CNS), leading
to demyelination. Myelin is the insulating sheath that surrounds
nerve cells (neurons). MS may cause numerous physical and mental
symptoms, and often progresses to physical and cognitive disability.
The World Health Organization (WHO) estimates that over 2.5 million
people globally suffer from MS, which represents a current market of
approximately $5.4 billion for disease-modifying agents to treat the
disorder.

About Pluristem

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated
to the commercialization of non-personalized (allogeneic) cell
therapy products for the treatment of several severe degenerative,
ischemic and autoimmune disorders. The Company is developing a
pipeline of products, stored ready-to-use, that are derived from the
human placenta, a non-controversial, non-embryonic, adult stem cell
source.

These placental mesenchymal stromal cells (MSCs) are expanded in the
Company's proprietary PluriX™ 3D bioreactor, which imitates the
natural microstructure of bone marrow and does not require
supplemental growth factors or other exogenous materials. Pluristem
believes the resultant PLX (PLacental eXpanded) cells are multi-
potent and able to differentiate into a variety of cell types. Recent
evidence also suggests their efficacy may be related to the secretion
of cytokines or other potent immune modulators. Furthermore, PLX
cells are immune privileged and have immunomodulatory properties,
thus protecting the recipient from immunological reactions that often
accompany transplantations.

Pluristem's first product, PLX-PAD, is intended to improve the
quality of life of millions of people suffering from peripheral
artery disease (PAD). The Company's PLX-I product is intended to
resolve the global shortfall of matched tissue for bone marrow
transplantation (BMT) by improving the engraftment of hematopoietic
stem cells (HSCs) contained in umbilical cord blood (UCB). PLX-STROKE
shows potential to become a new treatment for the functional recovery
from an ischemic stroke.

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

See our product animation on YouTube: http://www.youtube.com/watch?
v=OFhWXyJT6Us

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. 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.
For example, when we say that the Company's PLacental eXpanded (PLX)
cells showed a statistically significant advantage in ameliorating
functional deficiencies in a standard Multiple Sclerosis (MS) animal
model; that these results, in addition to our previously announced
PLX STROKE results, demonstrate that PLX cells may be useful in the
treatment of central nervous system (CNS) disorders and potentially
help millions of people; that we believe this experiment demonstrates
we can potentially utilize our off-the-shelf, easy to obtain PLX
cells and achieve results that are as good as or better than MSCs
obtained from other more difficult to find sources, we are using
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; 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; 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 risk 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.
Investor Contact:
William Prather RPh, MD, Sr. VP Corporate Development
303-883-4954
bill@pluristem.com

http://www.earthtimes.org/articles/show/pluristems-plx-cells-show-
a,350519.shtml

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StemCells subscribers may also be interested in these sites:

Children's Neurobiological Solutions
http://www.CNSfoundation.org/

Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123

The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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