Lead Physicians in Pluristem’s Pivotal Study in Critical Limb Ischemia Publish Peer-Reviewed Paper
May 15 2019 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, announced the publication of a peer-reviewed
article in the European Journal of Vascular and Endovascular
Surgery (EJVES) titled “PLX-PAD Cell Treatment of Critical Limb
Ischemia: Rationale and Design of the PACE Trial.” The article,
written by key physicians conducting the pivotal study, presents
the Company’s ongoing Phase III study evaluating PLX-PAD cell
therapy for the treatment of critical limb ischemia (CLI). The
pivotal study is also designed to measure long-term outcomes and
collect parameters to assess the potential economic benefit of this
kind of treatment. Additionally, an invited commentary that
also appears in EJVES lends strong support for the study’s design
and potential impact.
The paper cites the significant need that exists
for new and effective CLI treatment options when revascularization
is not an alternative, and the shortcomings and differentiation
from other therapies that have failed to demonstrate meaningful
benefits in controlled clinical studies to date. Pluristem’s
PLX-PAD cell therapy has been successfully evaluated in two Phase I
CLI studies, with additional supportive data from a Phase II
intermittent claudication (IC) study. In these studies, PLX-PAD
cells have demonstrated a favorable safety profile as well as
significant pain reduction, an increase in tissue perfusion, a
reduction in surgical events and significant improvement in HbA1c
(blood glucose control) and CRP levels (blood test marker for
inflammation in the body).
“Several therapies have been tested to meet the
medical need of these patients and have not succeeded in
demonstrating meaningful benefits to date,” commented Prof. Lars
Norgren, Department of Surgery, Faculty of Medicine and Health,
Örebro University, Sweden and lead author of the paper. “From an
immunological point of view, it has been shown that treatments
using the patient’s own cells, and in particular those with
cardiovascular risk factors or CLI, are reduced in functionality.
One reason Pluristem’s PLX-PAD cell therapy is so desirable is that
the young healthy placenta cells being used in the therapy are of a
better quality and have the potential for higher efficacy than
previously seen.”
“CLI is a widely recognized disease leading to
losses of limbs. With the aging of the world’s population, the
incidence of this problem continues to increase,” commented Dr.
John Lantis, MD, Vice Chairman of the Department of Surgery and
Chief of Vascular and Endovascular Surgery at Mount Sinai West and
a co-author of the paper. “For these patients who do not have
an option for revascularization, and those for whom the risks of
intervention outweigh the benefits, we need another option.
An intervention focused on office-based injections that could grow
new blood vessels could definitely be a game changer for many
patients. It is exciting to be a part of a study that may
truly give us a new medical option.”
“We are grateful for the opportunity to bring
CLI patients closer to a medical solution and we thank those who
are participating in the study, as well as the investigators who
are working to efficiently advance this important late-stage
study,” said Zami Aberman, Chairman and Co-Chief Executive Officer
of Pluristem. “Our goal is to make this potentially ground-breaking
treatment available to CLI patients, an underserved patient
population, as quickly as possible.”
Pluristem recently completed enrollment of half
of the study’s population (n=123). An interim analysis may be
allowed following a 12-month follow-up period and could support an
application for conditional marketing approval in Europe, under the
European Adaptive Pathways Program. The Company’s PLX-PAD CLI
program has also been granted Fast Track Designation, and selected
for an Expanded Access Program (EAP), by the U.S. Food and Drug
Administration (FDA) as well as awarded a €7.6 million grant from
the European Union’s Horizon 2020 Research and Innovation
Program.
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy product. The Company has reported robust clinical trial
data in multiple indications for its patented PLX cell product and
is currently conducting late stage clinical trials in several
indications. PLX cell product 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.
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 its PLX-PAD cell
therapy is desirable because placenta cells are of a better quality
and have the potential for higher efficacy, that an intervention
focused on office-based injections that could grow new blood
vessels may be a game changer for many patients and could provide a
new medical option, that Pluristem’s goals are to make the PLX-PAD
cell therapy available for patients as quickly as possible and that
Pluristem may be allowed to provide an interim analysis of its
PLX-PAD pivotal study within a 12 month follow up period which may
support an application for conditional marketing approval in Europe
under the European Adaptive Pathways Program. 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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