Pluristem Receives Approval to Expand Its Phase II Clinical Trial in Intermittent Claudication to Germany
January 15 2013 - 3:00AM
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-derived cell therapies, announced today that
the Paul-Ehrlich-Institute (PEI), the medical regulatory body for
biological medicinal products for the Federal Republic of Germany,
has approved the company's request to initiate a Phase II study
using PLX-PAD cells in patients suffering from Intermittent
Claudication (IC). IC is a subset of Peripheral Artery Disease
(PAD). According to The SAGE Group and HCUP 2007 Inpatient Data,
the prevalence of IC in the United States is approximately 14
million patients, representing a cost of approximately $2.5 billion
annually to the healthcare system.
"This approval is part of our previously announced strategy to
conduct a multi-national study using our PLX-PAD cells in this
disorder," said Zami Aberman, Chairman and CEO of Pluristem. "We
are in the process of opening three clinical sites in Germany where
the protocol will be same as the one used in the U.S. which has
already begun enrolling and dosing patients. Additionally, we plan
to expand into clinical sites in Israel, following regulatory
approval."
About the Study
Pluristem's IC Phase II is a randomized, placebo-controlled
trial that will evaluate the safety and efficacy of two doses of
PLX-PAD cells versus placebo, administered via intramuscular
injections. The study protocol is comprised of approximately 150
patients with IC: Fontaine class IIb, Rutherford category 2-3.
The primary efficacy end point of the trial is the change in the
maximal walking distance from baseline during an exercise treadmill
test. Secondary endpoints are hemodynamic and quality of life
measurements. Safety parameters are also being assessed.
About Intermittent Claudication
IC is a subset of PAD caused by atherosclerosis of the lower
extremity arteries. IC is characterized by muscle pain, such as
aching, cramping, numbness or a sense of fatigue classically in the
calf muscle, which occurs during exercise, such as walking and is
relieved by a period of rest. The prevalence of IC in the United
States alone is approximately 14 million patients and representing
a cost of approximately $2.5 billion annually to the National
Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient
Data).
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a
leading developer of placenta-based cell therapies. The Company's
patented PLX (PLacental eXpanded) cells are a drug delivery
platform that releases a cocktail of therapeutic proteins in
response to a host of local and systemic inflammatory and ischemic
diseases. PLX cells are grown using the company's proprietary 3D
micro-environmental technology and are an "off-the-shelf" product
that requires no tissue matching prior to administration. Pluristem
is focusing on the development of PLX cells administered locally to
potentially treat systemic diseases and potentially obviating the
need to use the intravenous route.
Pluristem has a strong patent and patent applications portfolio,
company-owned GMP certified manufacturing and research facilities,
strategic relationships with major research institutions and a
seasoned management team. For more information visit
www.pluristem.com, the content of which is not part of this press
release.
The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882
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, we are using forward-looking statements when we
discuss the process of opening three clinical sites in Germany or
our plan to expand into clinical sites in Israel, following
regulatory approval. 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; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, 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; our products may wind up being more
expensive than we anticipate; results in the laboratory may not
translate to equally good results in real surgical settings;
results of preclinical studies may not correlate with the results
of human clinical trials; 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 risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange Commission.
CONTACT: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
1-303-883-4954
William.PratherMD@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com