Pluristem Completes Interim Enrollment in Pivotal CLI Study, Targeting Potential Conditional Marketing Approval in Europe
April 29 2019 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing novel placenta-based cell therapy products, today
announced the Company has achieved a significant milestone in its
ongoing development of PLX-PAD for the treatment of critical limb
ischemia (CLI). The company has met its enrollment timelines
relating to its Phase III pivotal study in CLI sooner than
expected, and has successfully enrolled over 50% of the study’s
patients, which allows for an interim analysis of efficacy after a
one-year follow-up period under the European Medicine Agency’s
(EMA) Adaptive Pathways pilot project, which PLX-PAD was selected
for. The interim analysis, if positive, could support an
application for conditional marketing approval, which could
accelerate the approval and commercial availability of PLX-PAD in
the Europe.
Pluristem also announced today the official
initiation of its U.S. Food and Drug Administration (FDA)-approved
Expanded Access Program (EAP), with several site initiations in the
U.S. This program makes Pluristem’s PLX-PAD cell therapy product
available to CLI patients who are unsuitable for inclusion in the
Company’s ongoing multinational Phase III clinical study. The EAP
will enroll up to 100 patients with Rutherford Category 5 CLI and
provides Pluristem the opportunity to collect data while the global
Phase III study is ongoing. Pluristem previously announced that it
received approval from the FDA for cost recovery for patient
treatments administered under the EAP.
“Pluristem’s development program for its novel
cell therapy, PLX-PAD, for the treatment of CLI continues to
progress, and we are rapidly approaching a significant data
milestone with a potential interim efficacy analysis that could
expedite commercial availability in Europe,” stated Zami Aberman,
Chairman and Co-Chief Executive Officer of Pluristem. “We are
pleased to see positive collaboration from our clinical sites,
where we beat our expected timelines for patient enrollment. We
will use the remaining year to prepare the company for its
potential application for conditional marketing approval in Europe
under the adaptive pathway designation. We look forward to
conducting this interim analysis with the goal of making this
promising therapy available to patients as quickly as
possible.”
“CLI is a devastating disease that can result in
diminished quality of life and a high risk of amputation and death.
With lack of suitable non-surgical therapeutic options for the
growing population of CLI patients, new approaches such as cell
therapy are warranted. In multiple completed studies to date,
PLX-PAD demonstrated significant improvement in reducing the risk
for amputation and death, improved tissue perfusion and reduced
ischemic pain, all while demonstrating a very favorable safety
profile.” Mr. Aberman concluded, “We are glad to receive the FDA’s
support for our EAP and are privileged to be able to provide
PLX-PAD to patients in need, with the goal to prevent amputations
and save lives.”
The Phase III CLI program has been awarded a
€7.6 million grant from the European Union’s Horizon 2020 program,
which is its largest EU research and innovation program. The
collaborative project includes leading European research institutes
and clinical sites, which 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.
In addition to the EMA’s Adaptive Pathways
program and the FDA’s EAP, PLX-PAD has been granted FDA Fast Track
Designation for the treatment of CLI.
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy product candidates. The Company has reported robust
clinical trial data in multiple indications for its patented PLX
cell product candidates and is currently conducting late stage
clinical trials in several indications. PLX cell product candidates
are believed to 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; a
Company-owned and operated GMP-certified manufacturing and research
facility; strategic relationships with major research institutions;
and a seasoned management team.
About Critical Limb Ischemia
(CLI)Critical Limb Ischemia (CLI) is the most severe form
of peripheral artery disease (PAD), a chronic illness in which
blood flow to the limbs is obstructed. PAD is the most prevalent
cardiovascular disease in the world, affecting more than 200
million people, and one of the most common chronic diseases in the
U.S., surpassing even cancer. It is estimated that 5-6 million
people in U.S. and Europe suffer from CLI with an estimated cost of
25 billion $ per year in the U.S. alone. With the increasing rate
of aging and diabetes, this number is projected to grow in the
coming years. Today, up to 40% of CLI patients are unsuitable for
revascularization and experience up to 40% amputation rate at 1
year, left with no medical solution other than amputation.
Safe Harbor StatementThis 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 it discusses that the interim
analysis of the Phase III study, if positive, could support an
application for conditional marketing approval, which could also
accelerate the approval and commercial availability of PLX-PAD in
the European Union, the enrollment of patients and the expected
collecting of data in its EAP and the expected timing for the
preparation of a potential application for conditional marketing
approval in Europe under the adaptive pathway designation. 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:
Efrat KaduriDirector of Business, Investor and Public
Relations972-74-7108600efratk@pluristem.com
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