Pluristem’s Phase III Critical Limb Ischemia Study Wins $8 Million Grant from Europe’s Horizon 2020 Program
August 09 2016 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
that its critical limb ischemia (CLI) program in the European Union
has been awarded an $8 million grant. The grant is part of the
European Union’s Horizon 2020 program, which is its largest
Research and Innovation program. The Phase III study of PLX-PAD in
CLI will be a collaborative project carried out by an international
consortium led by the Berlin-Brandenburg Center for Regenerative
Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and
Prof. Petra Reinke together with Pluristem.
The consortium, which will include leading
European research institutes and clinical sites, will undertake an
extensive scientific program in parallel to the trial, using
in-depth immunological, endocrine, and molecular analyses to better
understand the mechanism of action of PLX-PAD in CLI.
As previously announced, Pluristem’s PLX-PAD
development program has been selected for the EU’s Adaptive
Pathways project, whose goal is to shorten the time it takes for
innovative medicines to reach patients with serious conditions that
lack adequate treatment options.
“We are honored to have been awarded this
Horizon 2020 grant designed to support the manufacturing and
development of our cell products for potential commercialization.
This grant is a vote of confidence and an expression of hope by the
European Union that we may be able to provide a regenerative
therapy for millions of CLI patients around the world. Pluristem is
committed to developing PLX-PAD for patients with peripheral artery
disease, and this grant will help us move towards our goal of rapid
entry into the European and U.S. markets, given positive results,”
stated Pluristem Chairman and CEO Zami Aberman.
The pivotal study for Pluristem’s PLacental
eXpanded (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 amputation and 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 regions. PLX-PAD cells are designed to address the
$12 billion global CLI market.
About the
Berlin-Brandenburg Center for Regenerative Therapies
The Berlin-Brandenburg Center for Regenerative
Therapies (BCRT) was founded as a cooperative research institution
of the Charité University Hospital in Berlin, which is one of the
largest university hospitals in Europe, and Germany's largest
research association, the Helmholtz Association. The goal of the
BCRT is to enhance endogenous regeneration by cells, biomaterials,
and factors which can be used to develop and implement innovative
therapies and products. The primary focus of the BCRT is on
diseases of the immune system, the musculoskeletal system and the
cardiovascular system for which currently only unsatisfactory
treatment options are available.
About the Adaptive Pathways
The purpose of Europe’s Adaptive Pathways is to
shorten the time it takes for innovative medicines to reach
patients with serious conditions that lack adequate treatment
options. The pathway is open to clinical programs in early stages
of development only. After a therapy is selected for the program,
the Adaptive Pathways group conducts high level discussions and
provides guidance to the applicant regarding the formal regulatory
processes that precede a trial targeting early approval and further
expansion of the indications.
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 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 obtaining the $8 million
grant as a part of the EU’s Horizon 2020 program, the estimated use
of the grant, the potential for obtaining conditional marketing
approval in Europe in the event of positive results of our pivotal
CLI trial and Pluristem’s intention to utilize the results of the
CLI trial in applying for regulatory approval in both the Europe
and the U.S. 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
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