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
Paul Ehrlich Institute (PEI) in Germany has approved the
pre-clinical study synopsis to support a Phase I/II
clinical trials in Germany and that the Center for
Biologics Evaluation and Research (CBER), a division of
the US Food and Drug Administration (FDA), has approved
the synopsis to conduct a Phase I clinical trial in the
US utilizing PLX-PAD for the treatment of limb ischemia
associated with peripheral artery disease (PAD). The PEI
is the German federal authority granting clinical trial
approvals.
PLX-PAD are mesenchymal stromal cells (MSCs) obtained
from the placenta and expanded using Pluristem’s
proprietary 3D PluriX™
technology
The regulatory and scientific package submitted to
both authorities contains detailed information on the
clinical indication, product properties, the Good
Manufacturing Practices (GMP) manufacturing process for
the production of PLX-PAD, and the clinical protocol
synopsis for the planned Phase I/II clinical trial. The
package also contains information on the safety and
biodistribution study designs required to file an
investigational new drug (IND) application.
Mr. Zami Aberman, Pluristem’s
President & CEO, stated: “I am
proud that our team has accomplished this important
milestone in achieving the FDA and PEI approval of our
clinical route. We believe that this now paves the way
to submit an IND using PLX-PAD for limb ischemia this
summer and hopefully begin our Phase I/II clinical
trials in 2008.”
About Limb Ischemia
In the US alone, it is estimated that 8-12 million
people suffer from limb ischemia associated with
peripheral artery disease (PAD). The disease is
characterized by narrowing and hardening of the arteries
in the patient’s limb(s)
caused and/or aggravated by conditions such as diabetes,
Buerger's Disease 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
current market for therapeutics and other interventions
to treat limb ischemia is estimated to be approximately
$1.2 billion.
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
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-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; PLX-STROKE, targeting ischemic stroke
victims; and PLX–MS,
targeting Multiple Sclerosis.
Pluristem has offices in the USA with research and
manufacturing facilities in Israel.
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. For example,
when we say that we believe that this now paves the way
to submit an IND using PLX-PAD for limb ischemia this
summer and hopefully begin our Phase I/II clinical
trials in 2008, we believe that this now paves the way
to submit an IND using PLX-PAD for limb ischemia this
summer and hopefully begin our Phase I/II clinical trial
in 2008, 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.
