NEW YORK--(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
Company signed an agreement with
Charité – Universitätsmedizin Berlin
and Franziskus-Krankenhaus Hospital
for the upcoming Critical
Limb Ischemia (CLI) clinical trials in
Germany utilizing Pluristem’s placental-derived
adherent stromal cell product, PLX-PAD.
Pluristem plans to
initiate its dose ranging clinical
trials at the Charité and the
Franziskus-Krankenhaus hospitals by
administering PLX-PAD to patients
afflicted with critical limb ischemia
who have not responded to traditional
medical or surgical interventions and
are facing amputation.
“Signing an agreement
with the Charite, a well respected
European institution, was accomplished
following the successful collection of
double blinded preclinical efficacy and
safety data, so the translation to the
human clinical trial looks very
promising”, stated Zami Aberman,
Chairman, President and CEO of Pluristem.
“We are honored to collaborate with the
Hospital and the Berlin-Brandenburg
Center for Regenerative Medicine (BCRT)”.
Mr. Aberman also stated: “Signing an
agreement with the Franziskus-Krankenhaus
Hospital is also very appropriate, due
to the Hospital’s considerable
experience and expertise in human stem
cell studies in peripheral artery
disease (PAD)”.
About BCRT
The Berlin-Brandenburg
Center for Regenerative Therapies (BCRT),
an integral part of Charité Universitätsmedizin,
Berlin, one of Europe’s largest
university hospitals, located within
Europe’s leading biotechnology region,
developed an internationally visible
center of excellence in regenerative
medicine with a focus on targeted cell
differentiation for promoting endogenous
tissue regeneration and
translating basic science
discoveries into regenerative therapies.
The BCRT is also sharing its scientific
knowledge in regenerative medicine with
researchers, clinicians, industry and
the public through educational
activities, training, publications, and
communication forums at national and
international levels.
About
Franziskus Hospital
Franziskus Hospital,
managed by the Sisters of the Franziskus
Order and located in Berlin, is a
medical and teaching hospital dedicated
to the treatment of vascular disorders.
It is composed of three main departments:
Vascular Medicine, Surgery and
Intervention. With approximately 180
beds, Franziskus Hospital is Germany’s
largest vascular center with more than
15,000 patients per year treated for
venous or arterial disorders. The
hospital has a unique focus on the cell-based
therapy of arterial occlusive disease.
About Critical Limb
Ischemia
In the US alone, it is
estimated that 8-12 million people
suffer from limb ischemia associated
with peripheral artery diseases (PAD).
The disease is characterized by
narrowing and hardening of the arteries
in the patient’s limb(s) caused and/or
aggravated by diabetes, Buerger's
Disease, other diseases and smoking.
With decreased blood flow to the
affected extremity, patients can suffer
a host of complications including nerve
and tissue damage. In advanced stages,
limb ischemia can lead to gangrene,
which often requires treatment with
amputation. The disease is associated
with a high rate of mortality and the
need for frequent hospitalization from
surgical complications.
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. The Company is
developing a pipeline of products,
stored ready-to-use, that are derived
from human placenta, a non-controversial,
non-embryonic, adult stem cell source.
These placental adherent
stromal cells (ASCs) are expanded in the
Company's proprietary PluriXTM
3D bioreactor, which imitates the
natural 3D microenvironment of these
cells and does not require supplemental
growth factors or other exogenous
materials. Pluristem believes that the
resultant PLX (PLacental eXpanded)
cells’ efficacy may be related to the
secretion of cytokines or other potent
immune modulators. Furthermore, PLX
cells are immune privileged and possess
immunomodulatory properties, thus
protecting the recipient from
immunological reactions that often
accompany transplantations.
Pluristem's first product
in development, PLX-PAD, is intended to
improve the quality of life of millions
of people suffering from peripheral
artery disease (PAD). The Company's
products in development also include
PLX-IBD, targeting Inflammatory Bowel
Disease (IBD); PLX-MS, targeting
Multiple Sclerosis; PLX-BMT, targeting
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; 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
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 signing an agreement
with the Charite was accomplished
following the successful collection of
double blinded preclinical efficacy and
safety data so the translation to the
human clinical trial looks very
promising, 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; 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.
For more information
visit our website at
www.pluristem.com, the content of
which is not part of this press release.
Contact:
Pluristem Therapeutics
Inc.
William Prather RPh,
MD
Sr. VP Corporate
Development
+1-303-883-4954
bill@pluristem.com
