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Pre-Clinical Study Shows Significant Advantage in
Functional Recovery Endpoints Versus Control
NEW YORK--(BUSINESS WIRE)--Pluristem Life Systems, Inc.
(OTCBB:PLRS) , a
bio-therapeutics Company dedicated to the commercialization of
unrelated donor-patient (allogeneic) cell therapy products for a variety of
malignant, degenerative and auto-immune indications, announced today
that results from Fraunhofer Institute’s
ongoing in vivo study, utilizing Pluristem’s
proprietary PLacenta eXpanded (PLX) cells in treating ischemic stroke,
showed initial promise as a potential therapy to treat stroke victims.
PLX cells are mesenchymal stem cells (MSCs) obtained from the placenta
and expanded using Pluristem’s proprietary 3D
PluriX™ technology.
Fraunhofer Institute’s scientists
systemically injected PLX cells into spontaneously hypertensive rats
that had undergone middle cerebral artery occlusion, a commonly accepted
ischemic stroke model. At the current stage, this animal trial shows a
significant advantage in functional recovery over a control group that
did not receive PLX cells.
Zami Aberman, Pluristem’s President and CEO
said: “We are very excited about the results
and believe that utilizing our PLX product may successfully treat
millions of ischemic stroke patients and lead to a multi-billion dollar
market. This independent study, together with the previously announced
favorable pre-clinical results of PLX cells to treat limb ischemia and
Parkinson's disease, give us a robust pipe line for developing new
therapeutic products following the foreseeable submission of the IND for
treatment of blood cancers.”
The trial is conducted under the supervision of Professor Frank
Emmrich, Head of the Fraunhofer Institute for Cell Therapy and
Immunology (IZI), Leipzig, Germany, a branch of the Fraunhofer Society.
Prof. Frank Emmrich stated, "PLX cells show potential to become a
treatment to functionally recover from a stroke. However, the
preliminary findings have to be confirmed and the running experimental
series have to be completed before a final statement can be made.
Additional optimization surrounding the administration of PLX cells will
be required to supply clear evidence that PLX cells may help patients
with ischemic stroke.”
Pluristem will present results of pre-clinical studies of its PLX
cells today, at the "3rd World Congress on Regenerative Medicine" in
Leipzig, Germany.
About Ischemic stroke
Ischemic stroke accounts for approximately 90% of all stroke cases
and is caused when an artery to the brain becomes blocked causing a
sudden disruption of blood flow. Current estimates suggest ischemic
stroke affects approximately 2 million patients annually worldwide with
a large percentage dying or becoming permanently disabled. Industry
leaders have estimated the potential market for treating ischemic stroke
to be approximately $4 billion.
About Pluristem
Pluristem Life Systems, Inc. is a Company dedicated to the
commercialization of unrelated donor-patient (allogeneic) stem cell therapy
products for the treatment of numerous severe degenerative, malignant
and autoimmune disorders. The Company's first planned product, PLX-BMT,
targets a $2 billion market and 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 (CB).
Pluristem's products are derived from mesenchymal stem cells (MSCs)
obtained from the placenta and expanded in the Company's proprietary
PluriX(TM) 3D bioreactor that imitates the natural microstructure of
bone marrow and does not require supplemental growth factors, cytokines
or other exogenous materials. Pluristem believes the resultant expanded
cells, termed PLX cells, are multipotent and able to differentiate into
a variety of cell types as well as being immune-privileged to protect
the recipient from immunological reactions that often accompanies
transplantation. Pluristem believes their future products will
participate in the approximate $30 billion therapeutic and regenerative
cellular market.
Pluristem has offices in the USA with research and manufacturing
facilities in Israel.
www.pluristem.com
Safe Harbor Statement
This press release contains statements, which may constitute
"forward-looking statements" regarding our intent, belief or current
expectations. Forward-looking statements in this release include that
ongoing in vivo study using PLX Cells shows initial promise in treatment
of stroke; that utilizing PLX cells in treating ischemic stroke may lead
to a product that penetrates a multi-billion dollar market; that PLX
cells’ immunosuppressive and immune
privileged characteristics may prove crucial in the treatment of a
variety of ischemic, malignant and auto-immune diseases; that this
independent study, together with the previously announced favorable
pre-clinical results of PLX cells to treat limb ischemia and Parkinson's
disease, give us a robust pipe line for developing new therapeutic
products following the foreseeable submission of the IND for treatment
of blood cancers. Factors that could prevent our forward looking
statements from being achieved include that we may be unable to get
regulatory approval for our products; we may be unsuccessful in
developing any products; 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 to protect essential aspects
of our technology; competitors may invent better technology; our
products may not work as well as hoped or worse, our products may harm
recipients; and we may not be able to raise funds for development or
working capital when we require it. As well, our products may never
develop into useful products and even if they do, they may not be
approved for sale to the public. For further risk factors see the
Company's latest 10-KSB filed with the SEC.
For more information visit our website at
www.pluristem.com . |
