Pluristem to Conduct Symposium on PLX-PAD Potential for the Treatment of Peripheral Artery Disease at a Multinational Confere...
September 08 2016 - 7:30AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading developer of placenta-based cell therapy
products, today announced that the Company is conducting a
Symposium on the potential for its placental expanded (PLX)PAD
cells in the treatment of peripheral artery disease. Pluristem’s
upcoming Phase III trial in Critical Limb Ischemia patients will be
presented as well. Pluristem’s Symposium is scheduled to take place
on Thursday, September 8, 2016 at the Third National Conference of
the German, Austrian and Swiss Societies of Vascular Medicine in
Dresden, Germany which will be attended by approximately 1,700
attendees from 16 different countries. The company recently
announced receiving an $8 million grant from the European Union’s
Horizon 2020 program to support the European trial.
One of the key topics of the conference is to
discuss the advanced treatments of peripheral vascular disease.
Physicians and researchers from specialties including angiology,
phlebology, internal medicine, interventional radiology and
vascular surgery will be attending the conference. Pluristem will
also be holding a meeting with investigators for the CLI study, to
review the study with them in more details.
“This is an opportunity time for Pluristem to
interact with the leading vascular specialists in Europe. Given the
potential of our PLX-PAD cells to offer a unique and much needed
treatment solution for CLI, we believe there will be strong
interest amongst attendees to take part in our upcoming Phase III
CLI trial,” stated Pluristem CEO Zami Aberman.
Professor Norbert Weiss, President of the
Conference and Principal Investigator of Pluristem’s Phase II
Intermittent Claudication (IC) trial commented, “This conference is
an ideal venue through which Pluristem can have a very meaningful
exchange with the vascular healthcare decision makers of Europe. As
the Principal Investigator of Pluristem’s Phase II IC trial, I
believe PLX-PAD cells have the potential to address difficult to
treat peripheral artery disease patients with a non-invasive and
potentially highly effective solution.”
Professor Nikol Sigrid, Principal Investigator
of Pluristem’s upcoming Phase III CLI trial, added, “We look
forward to commencing this important Phase III CLI trial. Among the
physicians attending this conference are some of the most active
specialists assessing and implementing new methods of treatment.
Upon regulatory approval in Europe, we believe these physicians may
be among the first to prescribe PLX-PAD for the benefit of their
patients.”
About the Phase III Trial in
CLI
The pivotal study for PLX-PAD cells in the
treatment of CLI is a double blind, randomized, placebo controlled
trial in an estimated 250 patients with CLI Rutherford Category 5
who are unsuitable candidates for revascularization. Patients will
be treated with 300 million cells or placebo, injected twice
intramuscularly (IM), with the second dose administered two months
after the first. The primary endpoint will be time to major
amputation or death. Patients will be enrolled in clinical sites
located throughout Europe and the U.S. Pluristem’s intention is to
utilize this study as a single pivotal trial for regulatory
approval in both the U.S. and Europe. PLX-PAD cells could
potentially address the $12 billion global CLI market.
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 cell products release
a range 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, forward-looking statements are used
in this press release when we discuss the upcoming Phase III trial
of Pluristem’s PLX-PAD cells, the potential for PLX-PAD cells to be
used in the treatment of Critical Limb Ischemia (CLI) and a range
of peripheral artery diseases, the description of the proposed
Phase III trial relating to PLX-PAD cells in the treatment of CLI,
including the number of estimated patients, the method of treatment
and the proposed locations for such clinical trial, the potential
for European physicians to be among the first to prescribe PLX-PAD
for the benefit of their patients and the potential for PLX-PAD
cells to address the $12 billion global CLI market. 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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