$7.9 Million Granted to nTRACK Collaborative Project Designed to Study Pluristem’s PLX-PAD Cells
October 02 2017 - 7:00AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
that a $7.9 million (€6.8 million) non-dilutive grant from the
European Union’s Horizon 2020 program has been awarded to nTRACK, a
collaborative project carried out by an international consortium
led by LEITAT.
The goal of the nTRACK project, initiated and
led scientifically by Prof. Rachela Popovtzer of Bar-Ilan
University in Israel, is to develop a safe, scalable, and highly
sensitive nanotechnology-based imaging approach to enable
non-invasive, whole body monitoring of injected stem cells in
humans, thereby providing early predictions of cellular therapy
treatment outcomes. The nTRACK consortium will utilize Pluristem’s
PLX-PAD cells to predict treatment success for muscle regeneration
following a gastrocnemius muscle injury. Final approval of the
grant is subject to the finalization of the consortium and Horizon
2020 grant agreements.
This marks Horizon 2020’s third grant to support
development of Pluristem’s PLX-PAD cell therapy product, following
an award of $8 million announced in August 2016 for Pluristem’s
ongoing multinational Phase III trial in the treatment of critical
climb ischemia (CLI) and an $8.7 million award announced in
September 2017 for the company’s Phase III study in the treatment
of muscle recovery following arthroplasty for hip fracture.
“We are honored to receive this additional grant
from the European Union to further develop our PLX-PAD program,”
said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe
the continued support from international governments is a vote of
confidence in our products, technology and methodology as our PLX
cell therapies undergo advanced development and brings us closer to
commercialization, offering new hope to patients and enabling them
to lead healthier lives.”
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 and is conducting
late-stage trials in several indications. The PLX 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, Pluristem
is using forward-looking statements when its discusses the format
and use of PLX-PAD cells in the nTRACK project, that the final
approval of the Horizon 2020 grant is subject to finalizing the
consortium and Horizon 2020 grant agreements and that Pluristem
believes the grant is a vote of confidence from international
governments in its methodology, technology, and products as its
cell therapies undergo advanced development and brings it closer to
commercialization, offering new hope to patients and enabling them
to lead healthier lives. 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:
Karine Kleinhaus, MD, MPH Divisional VP, North
America 1-914-512-4109 karinek@pluristem.com
Efrat Kaduri Head of Investor and Public
Relations 972-74-7108600 efratk@pluristem.com
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