Pluristem Receives Clearance from Germany to Initiate its Multinational Phase III Trial in Critical Limb Ischemia Targeting Early Conditional Marketing Approval
(Thomson Reuters ONE) -
* PLX-PAD cells could potentially obtain early conditional marketing approval
in Europe via the Adaptive Pathways pilot project based on positive interim
efficacy data from first 125 patients
* This approval joins those from the U.S. FDA and U.K. for this 250-patient
Phase III Trial
* Germany is Western Europe's largest market for Critical Limb Ischemia
* Enrollment expected to commence in the first half of 2017
HAIFA, Israel, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy
products, today announced that Germany's health regulatory agency, the Paul
Ehrlich Institute (PEI), has cleared Pluristem to begin enrollment in Germany
for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia
(CLI) in patients who are unsuitable for revascularization. The trial was
recently cleared by the United States' Food and Drug Administration (FDA) and
the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA).
PLX-PAD cells have been selected by the European Medicines Agency (EMA) to be
developed for CLI via the Adaptive Pathways pilot project. Under this regulatory
pathway, the multinational Phase III trial may potentially lead to early
marketing approval of PLX-PAD for CLI in Europe, based on interim efficacy data
from the first 125 patients that have completed a follow-up of 12 months. Data
from the entire 250 patients will be submitted to the U.S. FDA for a Biologics
License Application (BLA) targeting commercialization, and to the EMA to apply
for full marketing approval.
"The potential for early marketing approval is an important achievement for us,
and we are glad that we may help bring hope to CLI patients with no good
treatment options. It is gratifying to see that regulatory authorities around
the world are working to accelerate patient access to innovative treatments for
medical conditions, such as CLI, that are unmet medical needs," stated Pluristem
Chairman and CEO, Zami Aberman.
The global Phase III trial will evaluate PLX-PAD cells in the treatment of CLI
in a double-blind, randomized, placebo-controlled trial. An estimated 250
patients with CLI Rutherford Category 5, who are unsuitable candidates for
revascularization, will be enrolled. Patients will be treated with 300 million
cells or placebo, injected twice intramuscularly (IM) two months apart. The
primary endpoint will be time to amputation or death, allowing for a survival
analysis which enables collection of more data during the trial thereby
significantly reducing the number of patients needed, to allow statistically
significant results from a trial of this size.
About Critical Limb Ischemia
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced
blood flow. This causes leg pain at rest, non-healing ulcers and gangrene.
Patients with CLI are at high risk for limb amputation and death within a year
of diagnosis. While some conservative treatments exist to relieve pain, and
provide localized ulcer care, most patients will ultimately need a
revascularization procedure. CLI patients who cannot undergo revascularization
procedures are left with poor treatment options, and have a severe unmet medical
need. With over 700,000 citizens suffering from critical limb ischemia, Germany
represents the single largest Western European market, as per the Sage group
(2010). This reflects the fact that Germany has the highest regional prevalence
of diabetes, as well as the greatest number of elderly citizens, which are major
risk factors for CLI.
About the Adaptive Pathways Pilot Project
The purpose of EMA's Adaptive Pathways pilot project 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 cell
products 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 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 the timing of patient enrollment in our Phase III CLI trial, the
potential for expedited approval of PLX-PAD cells for the treatment of CLI in
Europe by the EMA, the review of patient data from the Phase III CLI study by
the EMA, the potential for the efficacy data as a result of the Phase III CLI
trial to support Pluristem's Biologics License Application and when we discuss
the potential for PLX-PAD cells to treat CLI. 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(at)pluristem.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Pluristem Therapeutics Inc. via GlobeNewswire
Datum: 17.01.2017 - 11:30 Uhr
Sprache: Deutsch
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