Pluristem to Initiate a Phase I/II Clinical Trial in Muscle Injury
November 14 2012 - 6:00AM
Pluristem Therapeutics, Inc. (Nasdaq:PSTI)
(TASE:PLTR), a leading developer of placenta-based cell therapies,
today announced it has initiated a Phase I/II clinical trial to
evaluate the safety and efficacy of its PLacental Expanded (PLX)
cells in the treatment of muscle injury. As previously reported,
the Paul Ehrlich Institute (PEI), the German competent authority in
the European Union, has granted the Company clearance to start the
trial which will be conducted at the Klinik für Orthopadie on the
campus of the Charité Universitatsmedizin in Berlin, Germany.
"Pluristem considers this clinical trial to be our entry into
the orthopedic and sports medicine markets. The response of the
gluteal muscle to our PLX cells will be an indication for us of how
well our cells would help various muscle injuries," stated Zami
Aberman, Chairman and CEO of Pluristem.
Study Summary:
In this Phase I/II trial, the muscle injury studied will be the
trauma sustained to the gluteal buttock muscle that occurs during
hip replacement. The most common type of hip replacement surgery
involves splitting the gluteal muscle to obtain access to the hip
joint. Previous muscle injury animal studies have demonstrated a
significant improvement in rehabilitation function and time by
using PLX cells over placebo. The endpoint of this study is to
observe if there is an improvement in the functional recovery of
the gluteal muscle as measured by maximal contraction force.
This randomized, double blinded, Phase I/II trial will evaluate
the safety and efficacy of two doses of PLX cells versus placebo
administered via intramuscular injections directly into the site of
the lacerated gluteal muscle before suturing. The study cohort is
comprised of approximately 18 patients equally divided between a
high and low dose PLX cell group and placebo group.
About Pluristem Therapeutics Inc.
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 use of PLX cells administered locally to treat
systemic diseases and potentially obviating the need to use the
intravenous route.
Pluristem has a strong patent portfolio, GMP certified
manufacturing and research facilities as well as strategic
relationships with major research institutions.
For more information visit www.pluristem.com and follow
Pluristem on Twitter @Pluristem, the content of which is not part
of this press release.
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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 value of the market our Product Candidate Targeting
Orthopedic and Sports Injuries addresses. 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 our clinical trials; 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; 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
Director Investor & Media Relations
+972-54-674-5580
daya@pluristem.com