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 , announced today that it has
filed an Investigational New Drug (IND)
application with the U.S. Food and Drug
Administration (FDA) to begin clinical
trials with its placental-derived
stromal cell product, termed PLX-PAD,
for the treatment of critical limb
ischemia.
Following clearance of
the IND application by the FDA,
Pluristem will initiate Phase I dose
ranging clinical trials during the first
half of 2009 at two clinical sites in
the U.S.A. As in the clinical trials
with PLX-PAD that are to begin in Europe
(see press release dated December 16,
2008), the patients in the U.S. trials
will be considered "late stage" and
defined as patients whose limb ischemia
has not responded to traditional medical
or surgical interventions and are facing
amputation.
Zami Aberman, Chairman,
President and CEO of Pluristem stated:
"We are pleased to be filing this IND
application in the U.S.A. Following
approval by the FDA, we will begin
administering PLX-PAD to patients
afflicted with critical limb ischemia
with the goal of proving this product
safe”. Mr. Aberman went on to say that:
"The IND application filed with the FDA
and the IMPD application filed in Europe
are two important steps in Pluristem's
global strategy to become a dominant
player in the cellular therapeutic
business arena”.
Edwin M. Horwitz, MD,
PhD, Director of Cell Therapy in the
Division of Oncology / Blood & Marrow
Transplantation at Children’s Hospital
of Philadelphia, an internationally
recognized authority on mesenchymal
stromal cells, and the Chairman of
Pluristem’s Scientific Advisory Board,
stated:
"This is an exciting time for Pluristem.
Success in this endeavor
will signify the first time an adult
stem cell, derived from the placenta and
grown using the Company's PluriX 3D
technology, has been administered to
humans safely. This will represent a
major advance in cell therapy and
position Pluristem as an international
leader in the field”.
Brian Annex, MD, Chief of
the Division of Cardiovascular Medicine,
Department of Medicine at the University
of Virginia School of Medicine and a
member of Pluristem’s Scientific
Advisory Board, stated: “If Pluristem’s
clinical trial is successful, this will
be a major advance in the field of
cellular therapeutics with the use of an
allogeneic off-the-shelf product that
needs no matching for peripheral
vascular disease and then, potentially,
other diseases”.
About CLI
In the US alone, it is
estimated that 8-12 million people
suffer from Critical Limb Ischemia (CLI)
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 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. Industry experts have
estimated the market for therapeutics
used in the treatment of limb ischemia
to be over $1 Billion. However, current
therapeutic methodologies have proven
ineffective for many severe limb
ischemic situations and have led the
medical community to call for the
development of cellular therapies, such
as Pluristem’s PLX-PAD, as alternative
treatments.
About Pluristem
Therapeutics
Pluristem Therapeutics
Inc. is a bio-therapeutics company
dedicated to the commercialization of
unrelated donor-patient (allogeneic),
off-the-shelf, 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 PluriX TM
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 critical limb
ischemia (CLI), an end stage of
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:
http://www.youtube.com/watch?v=OFhWXyJT6Us
For more information
visit our website at:
http://www.pluristem.com, the
content of which is not part of this
press release.
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 state that we will initiate
Phase I dose ranging clinical trials
during the first half of 2009, or that
we will begin administering PLX-PAD to
patients afflicted with critical limb
ischemia with the goal of proving this
product safe, or that the IND
application filed with the FDA and the
IMPD application filed in Europe are two
important steps in Pluristem's global
strategy to become a dominant player in
the cellular therapeutic business arena,
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:
failure to obtain required regulatory
approvals, 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:
William Prather RPh, MD
Sr. VP Corporate
Development
Ph: 303-883-4954
bill@pluristem.com
