Pluristem Completes 75% Enrollment in its Pivotal Phase III CLI Clinical Study
December 17 2019 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, today announced that it has enrolled 75% of the
246 patients planned for its Phase III clinical study of PLX-PAD in
the treatment of Critical Limb Ischemia (CLI), the most severe form
of peripheral artery disease, caused by fatty deposits in leg
arteries obstructing blood flow.
While an estimated 5 to 6 million people in the
U.S. and Europe suffer from CLI, up to 35% of patients are not
eligible for the standard-of-care treatment of revascularization
surgery. These patients are left with no treatment options and are
at high risk of leg amputation and death. Incidence of CLI is
increasing, driven by an aging population and a rise in risk
factors, including diabetes and obesity.
PLX-PAD is among the most advanced drugs under
development to treat CLI patients, with the goal to serve a large
population for which there is a significant need for therapy. “We
are pleased to be meeting our patient recruitment goals as we look
forward to completing this pivotal study,” stated Pluristem
President and CEO Yaky Yanay. “We aim to bring hope to millions of
CLI patients around the world by delivering a regenerative
treatment that can save limbs and lives while also saving costs for
the healthcare systems. We are pleased to receive significant
regulatory and financial support while developing such a novel
therapy for CLI, including fast track designation from the U.S.
Food and Drug Administration (FDA) and Adaptive Pathway designation
from the European Medicine Agency (EMA) that may enable faster
regulatory approvals. We understand the importance of a successful
outcome in this study for the benefit of this large population of
patients and for the benefit of all of our stakeholders. We at
Pluristem are fully committed to deliver the first and leading drug
for CLI patients across the globe.”
PLX-PAD has been selected for the EMA’s Adaptive
Pathways pilot project, allowing for potential accelerated approval
in Europe based on an interim analysis of half of the patients in
the study. In the U.S., PLX-PAD was granted a fast track
designation and was accepted to an expanded access program by the
FDA. €7.6 million has been granted to Pluristem’s Phase III CLI
program – the PACE study, from the European Union’s Horizon 2020
program, the largest EU research and innovation program. The Phase
III randomized, double blind, placebo-controlled study is enrolling
246 CLI patients who are unsuitable for revascularization in over
50 sites across Europe, the U.S., and Israel. Patients are treated
with two intramuscular treatments of 300 million cells of PLX-PAD
or placebo, at a randomized ratio of 2:1. The primary efficacy
endpoint is time to occurrence of a major leg amputation or
death.
About Pluristem
Therapeutics
Pluristem 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.
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 it
discusses the potential of its PLX-PAD to become the first and
leading drug approved to treat CLI patients across the globe, that
its PLX-PAD drug is being targeted to serve a large population for
which there is a significant need for therapy, the potential of
Pluristem and its study to deliver a regenerative treatment that
can save limbs and lives while also saving costs for the healthcare
systems and the potential for accelerated regulatory approvals in
the U.S. and Europe. 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 Kaduri Director of Business, Investor and
Public Relations972-74-7108600efratk@pluristem.com
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