Peer-Reviewed Article Published on Pluristem’s PLX-PAD Cells’ Mechanism of Action to Restore Blood Flow in Ischemic Tissu...
November 29 2017 - 7:00AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced the
publication of a peer-reviewed article in Cytotherapy, the official
journal of the International Society for Cellular Therapy, titled,
“Placenta-Derived PLX-PAD Mesenchymal-Like Stromal Cells are
Efficacious in Rescuing Blood Flow in Hind Limb Ischemia Mouse Model
by a Dose- and Site-Dependent Mechanism of Action (MOA).” The
article is based on the Company’s preclinical findings and will be
published in the December 2017 issue of Cytotherapy.
The study utilized a mouse model of hind limb
ischemia (HLI) to study the efficacy and MOA of PLX-PAD cells in the
treatment of peripheral artery disease (PAD). Pluristem is
currently conducting a global, pivotal Phase III study in critical
limb ischemia (CLI), and is expecting clinical data from its Phase
II study in intermittent claudication (IC). Both are forms of
peripheral artery disease. In both conditions, blood supply to the
legs is obstructed, leading to impaired blood flow and tissue
ischemia.
Data from this study showed that intramuscularly
(IM) administered PLX-PAD cells restored blood flow to the lower
limbs of mice with HLI, in a dose- and site-dependent manner. IM
administration of PLX-PAD cells had a systemic effect, thereby
restoring blood flow to parts of the limb in need even when
injected to the contralateral leg. Administration of a second dose
was found to boost the effect of a single administration and lead
to greater improvement in blood flow. The study demonstrated the
cells’ MOA: secreting therapeutic proteins systemically that
promote the creation of new blood vessels.
“We are pleased to share these findings, which
suggest the potential of our cells to secrete an adaptive,
slow-release cocktail of therapeutic proteins via their interaction
with tissue surrounding the area in need of healing and repair,”
stated Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe
this data supports our current pivotal trial in CLI by affirming
our dosing methods and quantities. The data is also valuable in
understanding the therapeutic role of PLX products in additional
medical indications. We believe these important findings also
provide additional support for the scientific rationale behind our
unique mechanism of action, and for the systemic effect and
therapeutic benefits of injecting the cells intramuscularly.”
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, and is entering late-stage
trials in several indications. Our PLX cell products release a
range of therapeutic proteins in response to inflammation,
ischemia, muscle trauma, hematological disorders, and radiation
damage. The cells are grown using the Company's proprietary
three-dimensional expansion technology and can be administered to
patients off-the-shelf, without tissue matching. 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 express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, Pluristem is using forward-looking statements when its
discusses the various studies relating to its cell therapy
products, Pluristem’s belief that the findings of the preclinical
HLI study support its dosing methods and quantities, the scientific
rationale of its unique MOA and the positive influence of IM
Injections on the systemic therapeutic effect of the cells as well
as its understanding of the therapeutic role of PLX products in
additional medical indications. 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;
Pluristem may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; Pluristem’s products
may not be approved by regulatory agencies, Pluristem’s technology
may not be validated as it progresses further and its methods may
not be accepted by the scientific community; Pluristem may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with Pluristem’s process; Pluristem’s
products may wind up being more expensive than it anticipates;
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; Pluristem’s
patents may not be sufficient; Pluristem’s products may harm
recipients; changes in legislation may adversely impact Pluristem;
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:
Karine Kleinhaus, MD, MPH Divisional VP, North
America 1-914-512-4109
karinek@pluristem.com
Efrat Kaduri Head of Investor and Public
Relations 972-74-7108600 efratk@pluristem.com
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