Pluristem Completes Enrollment for Phase I/II Muscle Injury Trial
11 Julho 2013 - 4:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today it has
completed the target enrollment in a randomized, double-blinded,
placebo controlled Phase I/II clinical trial to assess the safety
and efficacy of its PLacental Expanded (PLX) cells for the
treatment of traumatized muscles. All patients have been treated
with PLX-PAD cells or placebo and are currently in the follow up
stage of the trial.
The study is being conducted at the Orthopedic Clinic on the
campus of the Charité University Medical School in Berlin, Germany
and is under the oversight of Germany's healthcare regulatory
bodies, the Paul Ehrlich Institute (PEI) and Berlin's Ethic
Committee, LaGeSo.
In this trial patients were injected with either PLX-PAD cells
or placebo directly into their gluteal muscles that had been
surgically traumatized during hip replacement surgery. The primary
endpoint of the study is to assess the safety and efficacy of
PLX-PAD cells in evaluating the rehabilitation of the muscle
activity of the patient at six months following treatment.
Secondary efficacy endpoints include Magnetic Resonance Imaging
(MRI) and macroscopic and microscopic structure of the involved
gluteal muscles from biopsies taken at three months post therapy
(Reference:
http://clinicaltrials.gov/ct2/show/NCT01525667?term=pluristem&rank=3).
"Having treated all patients in this trial, we have reached a
milestone. The ease of use of our allogeneic, off-the-shelf product
enabled us to complete recruitment quickly and efficiently.
Following completion of the follow up period, we will obtain data
on the safety and efficacy of PLX-PAD cells in the treatment of
traumatized muscles during hip replacement surgery" stated Zami
Aberman, Chairman and CEO of Pluristem. "This trial is important as
it marks the first time PLX-PAD cells have been used in patients
following surgically induced muscle trauma. It also provides data
on the potential use of PLX cells for the treatment of sports
related injuries."
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 our Phase I/II muscle injury
trial and that we will obtain data on the safety and efficacy of
PLX-PAD cells in the treatment of traumatized muscles as well as
data on on the potential use of PLX cells for the treatment of
sports related 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