Pluristem Reaches Milestone in its Phase III Muscle Injury Study, Completes 50% Enrollment
December 03 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 completed enrollment of 50% of the 240
patients planned for its ongoing Phase III PLX-PAD study of muscle
regeneration.
There are currently no approved treatments for
the post-operative regeneration of injured or weak skeletal muscle,
and up to 30% of hip fracture patients die within one year of
surgery due to long-term complications resulting from immobility,
with high financial costs of hospitalization and
rehabilitation.
Pluristem’s ongoing Phase III multinational,
randomized, double-blind and placebo-controlled study is assessing
patients’ physical performance scores 26 weeks following surgery
after administrating allogeneic PLX-PAD cells for the treatment of
muscle injury following arthroplasty for hip fracture, as compared
to placebo. Additional efficacy endpoints include muscle strength,
muscle mass and volume, hospitalization time and lower extremity
measure. Through clinical sites in the U.S., Europe and Israel, 240
patients are being randomized on a 1:1 allocation to be dosed with
150 million PLX-PAD cells or placebo on the day of surgery.
This Phase III study follows positive results
from a Phase I/II study which demonstrated muscle regeneration when
using PLX-PAD cells in total hip arthroplasty patients. The study
demonstrated a significant change in muscle volume (p=0.004) and in
muscle force (p=0.0067) at 6 months post-surgery, compared to the
control group.
Pluristem CEO, Yaky Yanay, stated, “This study
marks an important milestone for Pluristem, as we are moving
forward with our main global studies and remain on track with
recruitment. We believe that our advanced clinical pipeline is
geared to bring regenerative medicine into standard-of-care use in
hospitals and clinics while providing reduced costs for the
healthcare systems. We are grateful to work with dedicated
physicians around the world, and with the European Horizon 2020
Program which is funding this study with €7.4 million.”
The Principal Investigator of the study, Dr.
Tobias Winkler of the Berlin Institute of Health for Regenerative
Therapies, Julius Wolff Institute and Center for Musculoskeletal
Surgery, commented, “We are eager to evaluate PLX-PAD’s ability to
aid muscle regeneration in patients recovering from arthroplasty
for hip fracture. Many patients do not fully recover after surgery,
suffering considerable morbidity due to poor muscle regeneration
and impaired mobility. PLX-PAD has the potential to improve and
extend quality of life for patients with one simple injection of
the cell therapy product.”
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 that its PLX-PAD cells are being targeted to be the first
product candidate supporting muscle regeneration after significant
trauma such as hip fracture, the potential of its clinical pipeline
to bring regenerative medicine into standard-of-care use in
hospitals and clinics while providing reduced costs for the
healthcare systems and the potential of PLX-PAD to improve and
extend the quality of life for patients. 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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