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Pluristem's Second Pre-Clinical Study in Ischemic Stroke Shows Statistically
Significant Advantages in Functional and Anatomical Recovery
Monday April 7, 10:00 am ET
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NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics
Inc. (NASDAQ:PSTI
- News) (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 the results from Fraunhofer Institute’s
additional pre-clinical study utilizing the Company’s
proprietary PLacental eXpanded (PLX) cells in treating ischemic
stroke showed statistical significance utilizing functional as well
as anatomical endpoints. PLX cells are mesenchymal stromal 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. The functional
endpoints of improvement in beam walking and neurological severity
score and the anatomical endpoint of reduction in infarct size
reached statistical significance versus controls.
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 blood cancer, give us a robust pipe
line for developing new therapeutic products.”
The trial was 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 possibly show
potential to become a new treatment for the functional recovery from
a stroke. The data show that a double injection of PLX cells at two
different time points significantly improve the functional recovery
and reduce of size of the lesion compared to the control. However,
these 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.”
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 Fraunhofer Institute for Cell Therapy and
Immunology
The Fraunhofer Institute for Immunology and Cell
Therapy (IZI) founded in April 2005 is member of the Fraunhofer Life
Sciences Alliance. Its objective being to find solutions to specific
problems at the interfaces between medicine, life sciences and
engineering for partners active in medicine-related industries and
businesses. The Institute’s core
competencies are to be found in regenerative medicine, or more
precisely in cell-therapeutic methods of regenerating
non-functioning tissue and organs through to the biological
substitution with tissue cultivated in vitro (tissue engineering).
In order for the living organism to accept the tissues without any
difficulty, it is necessary to study cellular and immunological
defense and control mechanisms and take these into account during
process and product development. These core competencies entail a
multiplicity of tasks to be solved by new products and processes.
The Institute works especially closely with hospital institutions,
performing quality tests and clinical studies on their behalf.
Additionally it also provides assistance in obtaining manufacturing
licenses and certifications.
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-BMT 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 our
pre-clinical study in ischemic stroke shows statistically
significant advantages in functional and anatomical recovery; that
we believe that utilizing our PLX product may successfully treat
millions of ischemic stroke patients and lead to a multi-billion
dollar market; that this independent study, together with the
previously announced favorable pre-clinical results of PLX cells to
treat limb ischemia and blood cancer, give us a robust pipe line for
developing new therapeutic product;, we are using a 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.
Contact:
Source: Pluristem
Therapeutics Inc.
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