Pluristem Granted Key U.S. Patent for Skeletal Muscle Regeneration - a Meaningful Asset Ahead of Upcoming Phase III Femoral N...
November 22 2017 - 7:00AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that the U.S. Patent and Trademark Office (USPTO) has issued a
patent titled, “Skeletal muscle regeneration using mesenchymal
system cells.” This key patent, which has already been granted in
Europe, Hong Kong and Israel, addresses the use of MSCs for
skeletal muscle regeneration used either directly after, or shortly
after, post-surgical muscle injury.
The Company received positive feedback from the
U.S. Food and Drug Administration (FDA) and the European Medicine
Agency (EMA) for the proposed study design and endpoints of its
Phase III trial for the treatment of muscle recovery following
arthroplasty for hip fracture. This planned study was recently
awarded an $8.7 million grant by the Horizon 2020 program, the
European Union’s largest research and innovation program. If
successful, Pluristem plans to use the study results to achieve
marketing approval in both the U.S. and Europe.
Previous clinical studies using PLX-PAD cells
demonstrated significant muscle regeneration following
arthroplasty, including a 300% improvement in muscle volume
(p=0.004) and a 500% (p=0.0067) boost in muscle force when observed
six months after surgery compared to the control group.
“This very important patent comes at the right
time, just ahead of our planned Phase III study in muscle
regeneration following hip fracture,” stated Zami Aberman, Chairman
and Co-CEO of Pluristem. “The patent substantially strengthens our
intellectual property around muscle regeneration, particularly as
it pertains to repair and regeneration following surgery. In an
industry that demands constant technological and scientific
advances, a robust patent portfolio covering our core innovations
strengthens Pluristem’s competitive edge.”
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 entering late-stage
trials in several indications. PLX cell products 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; 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 positive feedback it received from regulatory
authorities and the potential that such feedback will result in
approval to conduct clinical trials, the actual receipt of grants,
the initiation and successful completion of planned clinical
trials, the potential to receive marketing approval for Pluristem’s
products and the potential of the patent reported above to and
other intellectual property rights Pluristem owns to support
Pluristem’s competitive edge. 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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