Pluristem's Phase I/II Muscle Injury Trial Successfully Meets Primary Safety & Efficacy Endpoints
January 21 2014 - 2:05AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, today announced
top-line results from its Phase I/II clinical trial testing the
safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the
treatment of muscle injury. The trial indicated PLX-PAD cells were
safe and statistical significance was reached (p=0.0067) for the
primary efficacy endpoint of the study, the change in maximal
voluntary isometric contraction force of the gluteal muscle at six
months after total hip replacement. Patients treated with PLX-PAD
had a greater improved change of maximal voluntary muscle
contraction force than the placebo group. These results provide
evidence that PLX cells may be efficacious in the treatment of
orthopedic injuries including muscles and tendons.
This Phase I/II trial was a randomized, placebo-controlled,
double-blinded study conducted at the Orthopedic Clinic of the
Charité University Medical School under the auspices of the
Paul-Ehrlich-Institute (PEI), Germany's health authority. The
injured muscle studied was the gluteus medius muscle in the
buttock. Total hip replacement surgery via the standard
transgluteal approach necessitates injury of the gluteus medius
muscle, and post-operative healing is crucial for joint stability
and function.
The 20 patients in the study were randomized into three
treatment groups. Each patient received an injection in the gluteal
muscle that had been traumatized during surgery. One group was
treated with 150 million PLX-PAD cells per dose (n=7), the second
was administered 300 million PLX-PAD cells per dose (n=6), and the
third received placebo (n=7).
The primary safety endpoint was clearly met, with no serious
adverse events reported at either dose level. The study showed that
PLX-PAD cells were safe and well tolerated.
The primary efficacy endpoint of the study was the change in
maximal voluntary isometric contraction force of the gluteal muscle
at six months post-surgery. Efficacy was shown in both PLX-PAD
treated patient groups, with the group receiving the 150 million
cell dose displaying a statistically significant 500% improvement
over the placebo group in the change of the maximal contraction
force of the gluteal muscle (p=0.0067). Patients
treated at the 300 million cell dose showed a 300% improvement over
the placebo (p=0.18).
An analysis of the macrostructure of the gluteal muscle using
magnetic resonance imaging (MRI) indicated an increase in muscle
volume in those patients treated with PLX-PAD cells versus the
placebo group. This efficacy endpoint was demonstrated in both
PLX-PAD treated patient groups, with the group receiving the 150
million cell dose displaying a statistically significant
superiority over the placebo group. Patients treated at the 150
million cell dose showed an approximate 300% improvement over the
placebo in the analysis of muscle volume (p=0.004). Patients
treated at the 300 million cell dose showed an approximate 150%
improvement over the placebo in the change of muscle volume
(p=0.19). The complete dataset that includes biopsy results and
functional assessments will be presented at a medical conference
once the final analyses are completed.
The study's Senior Scientist, Dr. Tobias Winkler of the Center
for Musculoskeletal Surgery, Julius Wolff Institute Berlin, Charité
– Universitaetsmedizin Berlin, Germany, commented, "I am very
impressed with the magnitude of the efficacy results seen in this
trial. PLX cells demonstrated safety and suggested that the
increase in muscle volume could be a mechanism for the improvement
of contraction force."
Zami Aberman Chairman and CEO stated, "This was a very important
study not only for Pluristem but for the cell therapy industry in
general. The study confirms our pre-clinical findings that PLX-PAD
cell therapy can be effective in treating muscle injury. Having a
statistically significant result for our primary efficacy endpoint
is very encouraging and consistent with our understanding of the
mechanism of action associated with cell therapy. Based on these
results, we intend to move forward with implementing our strategy
towards using PLX cells in orthopedic indications and muscle
trauma."
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 results of our clinical
trial and that PLX cells may be efficacious in the treatment of
orthopedic injuries including muscles and tendons, or our intention
to move forward with implementing our strategy towards using PLX
cells in orthopedic indications and muscle trauma, 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.
In addition, historic results of scientific research and clinical
and preclinical trials do not guarantee that the conclusions of
future research or trials would not suggest different conclusions
or that historic results referred to in this press release would be
interpreted differently in light of additional research and
clinical and preclinical trials results. 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.:
Karine Kleinhaus, MD, MPH
Director of Investor Relations
1-914-512-4109
karinek@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Sep 2023 to Sep 2024