Pluristem Advances its Multinational Phase III Critical Limb Ischemia Study, Targeting Initiation at 40 Active Sites by the E...
10 July 2017 - 9:00PM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that Austria’s regulatory health agency, the Austrian Agency for
Health and Food Safety (AGES), has cleared Pluristem to begin
enrollment in Austria for its pivotal Phase III trial of PLX-PAD
cells to treat Critical Limb Ischemia (CLI). The trial is currently
enrolling patients in the U.S., U.K., and Germany.
Pluristem’s PLX-PAD cell therapy is one of a few
therapies in the world to have been selected to take part in the
European Medicines Agency’s (EMA) Adaptive Pathways pilot project,
which goal is to streamline development for promising innovative
medicines to allow for early access in patients with serious
conditions that lack adequate treatment. An interim efficacy
analysis is planned to be conducted based on data from the first
125 patients. Positive results are expected to lead to early
conditional marketing approval in Europe.
The Phase III CLI trial has received an $8
million grant from the European Union’s Horizon 2020 program, which
will cover a significant portion of the costs of the multinational
trial. Following the completion of the study, data from all 250
participants will be submitted to the EMA to apply for full
marketing approval and will be reviewed by the U.S. FDA for a
Biologics License Application (BLA) targeting
commercialization.
“CLI is a severely debilitating and
life-threatening disease that affects tens of millions of patients
around the world. Approval for this trial and its innovative
time-to-event endpoint by regulatory bodies worldwide reinforces
our belief that our PLX-PAD cell therapy has great potential to
successfully treat these patients and enable them to lead long and
healthy lives,” said Zami Aberman, Chairman and Co-CEO of
Pluristem. “The potential for early marketing approval is of key
importance for us and we plan to continue our mission to utilize
cell therapies to help combat devastating medical conditions.”
About the Study
CLI is an advanced stage of peripheral artery
disease, where fatty deposits block arteries in the legs, severely
reducing blood flow and causing pain, non-healing ulcers, and
gangrene. Patients with CLI are at a high risk of amputation and
death, and those unsuitable for revascularization are left with no
adequate treatment options.
The Phase III trial will enroll a total of 250
patients across an estimated 40 clinical sites to evaluate PLX-PAD
in the treatment of CLI in a double-blind, randomized,
placebo-controlled trial. The patients will all have CLI Rutherford
Category 5 – making them unsuitable candidates for
revascularization. The patients will be injected twice
intramuscularly (IM), two months apart, with 300 million cells or a
placebo. The primary endpoint will be time to amputation or death,
allowing for a survival analysis and increased data collection to
reduce the number of patients required while still enabling
statistically significant results for the trial.
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 different cell
products each release their own 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. No tissue
matching is required to administration of PLX cell products.
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 express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, we are using forward-looking statements when we discuss
our pivotal Phase III trial of PLX-PAD cells, the expected interim
efficacy analysis planned to be conducted based on data from the
first 125 patients, our expectations that positive results from the
Phase III CLI trial, if achieved, are expected to lead to early
conditional marketing approval in Europe, the expected submission
of study data from all 250 participants to the EMA in relation to
the application for full marketing approval and a BLA to the FDA
targeting commercialization, when we discuss the potential for
PLX-PAD cells to treat CLI and when we discuss our plan to continue
our mission to utilize cell therapies to help combat devastating
medical conditions. 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.
Contact:
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
Efrat Kaduri
Head of Investor & Public Relations
972-74-710-8600
efratk@pluristem.com
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