Pluristem Expands PLX Product Portfolio in Orthopedics and Sports Medicine
18 Avril 2013 - 9:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today it is
expanding its presence in the orthopedic and sports medicine
markets with plans to initiate a Phase I clinical trial to evaluate
the safety and efficacy of the local administration of PLX cells to
patients suffering from injuries to tendons. This study planned
will be a randomized, double blind, placebo-controlled study to
evaluate the safety and efficacy of local intra-tendon injections
of PLX-PAD cells to patients suffering from rotator cuff tear
requiring arthroscopic repair. The hypothesis is that PLX-PAD cells
will improve the post-operative structural and functional status of
the rotator cuff. This placebo controlled study will be conducted
in approximately 30 patients with a follow-up period of 6 months.
Tendinosis, sometimes called chronic tendonitis, is an
accumulation over time of micro tears of the connective tissue in
and around the tendon that does not heal properly. Tendinosis leads
to pain and a reduced range of motion. If left untreated,
tendinosis may lead to reduced tensile strength that increases the
chance of tendon rupture. Current therapies involve prolonged rest
and immobilization. Rotator cuff tendinosis is a very common
problem with more than 50% of individuals older than 60 years
presenting with at least a partial-thickness rotator cuff tear.
According to the American Academy of Orthopedic Surgeons, each year
approximately 200,000 Americans require surgery related to repair
of the rotator cuff. However full recovery after rotator cuff
surgery often takes 4 to 6 months and approximately 65% of the
patients undergoing rotator cuff repair will have a satisfactory
result one year following surgery.
"We have preclinical data illustrating the potential efficacy of
PLX cells in the treatment of tendon pathologies, conditions which
impact a large segment of the population. Intra-tendon injections
of PLX cells will potentially allow us to provide the focused
delivery of therapeutic proteins in the treatment of tendon
injuries. This trial represents the expansion of our orthopedic and
sports injury franchise and is additive to our current ongoing
study in muscle injury," stated Zami Aberman, Pluristem's Chairman
and CEO.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. 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 has a strong intellectual property position,
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, when we discuss the Phase I Trial in rotator
cuff injuries which we plan to initiate, when we discuss the
hypothesis that PLX-PAD cells will improve the post-operative
structural and functional status, or when we say that Intra-tendon
injections of PLX cells will potentially allow us to provide the
focused delivery of therapeutic proteins in the treatment of tendon
injuries, we are using forward-looking statements. These
forward-looking statements and their implications 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