Pluristem Reports Data Showing PLX-PAD Cells Effective in Treating Duchenne Muscular Dystrophy
June 22 2016 - 3:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI), (TASE:PSTI)/(PLTR), a
leading developer of placenta-based cell therapy products, today
reported positive data from preclinical studies of its PLX-PAD
cells in the treatment of Duchenne muscular dystrophy. The studies
were conducted in conjunction with ADI, the Association Duchenne
Israel, whose members are parents of children with Duchenne. They
are committed to helping to find a cure for Duchenne muscular
dystrophy through research, clinical trials, and advocacy.
Duchenne muscular dystrophy is the most common
neuromuscular disorder, and affects roughly one in 3,500 boys. The
disease causes progressive muscle weakness, and leads to severe
disability and death. There is currently no cure.
Following Pluristem’s announcement of positive
results from a Phase II clinical trial of PLX-PAD as a treatment
for muscle injury, the Association Duchenne Israel approached
Pluristem with a request to study PLX-PAD cells in Duchenne
muscular dystrophy. Pluristem donated PLX-PAD cells for the
preclinical studies, and the association supported the research in
cooperation with Science in Action Ltd.
The studies demonstrated that, in a mouse model
of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase
(CPK), a marker of muscle degeneration or injury, by approximately
50% as compared to placebo. CPK levels were measured via a blood
sample taken 5 days after each intramuscular PLX-PAD injection made
at day 15 and day 29 of the study. Histological analyses of
quadriceps and diaphragm muscles show PLX-PAD reduced levels of
inflammation and necrosis, a type of cell death, and induced
regeneration of muscle tissue.
Hila Krupsky, CEO of ADI, the Association
Duchenne Israel, stated, “These preclinical data suggest that
PLX-PAD cells could possibly be a breakthrough therapy to help
treat symptoms of Duchenne muscular dystrophy. We are thankful for
Pluristem’s donation of PLX-PAD and are eager to continue studying
the cells since new therapeutic approaches are needed to manage
this disease, save children's lives, and give them hope and a
chance for the future.”
“Because PLX-PAD cells have already displayed
efficacy in muscle regeneration in a Phase II muscle injury study,
we believe our cell therapy may potentially be beneficial in
Duchenne muscular dystrophy in human clinical trials,” said
Pluristem Chairman and CEO Zami Aberman. “We admire the commitment
of the Association Duchenne Israel to find a cure for Duchenne
muscular dystrophy, and we will work closely with them in an effort
to develop a treatment for the children around the world who suffer
from this disease.”
About Duchenne Muscular
Dystrophy
Duchenne muscular dystrophy (DMD) is a genetic disorder
characterized by progressive muscle degeneration and weakness. It
is caused by a shortage of dystrophin, a protein that helps
keep muscle fibers intact as they contract and relax. This shortage
is due to a mutation in the gene that controls the production of
dystrophin. Muscle weakness can begin as early as age 3, and by the
early teens the heart and respiratory muscles also are affected.
Average life expectancy for people with DMD is 27 years, though
there is significant individual variability. Although girls can be
carriers and mildly affected, the disease typically affects boys,
and there is currently no cure.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of placenta-based cell therapy products. The Company has
reported robust clinical trial data in multiple indications for its
patented PLX (PLacental eXpanded) cells. The cells release a
cocktail of therapeutic proteins in response to inflammation,
ischemia, hematological disorders, and radiation damage. PLX cell
products are grown using the Company's proprietary
three-dimensional expansion technology. They are off-the-shelf,
requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property
position; Company-owned and operated, GMP-certified manufacturing
and research facilities; strategic relationships with major
research institutions; and a seasoned management team.
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 findings of the study of our cell
therapy and its potential to treat symptoms of, or be part of a
possible cure for, DMD and that we will work closely with the
Association Duchenne Israel in an effort to develop a treatment to
this disease. 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 clinical 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. 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
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
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