Pluristem Therapeutics Announces Publication in JCSM of Two-Year Follow-Up Data from Phase I/II Study in Muscle Regeneration ...
October 10 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, today announced that two-year follow-up data from
its Phase I/II clinical study evaluating its allogeneic
placenta-derived cell therapy product, PLX-PAD, for the treatment
of muscle injury following hip replacement was published in the
peer-reviewed Journal of Cachexia, Sarcopenia and Muscle.
Pluristem also announced that its ongoing Phase
III study in the treatment of muscle injury following hip fracture,
which is underway in the U.S. and Israel, has been cleared to
enroll additional patients in Denmark, Germany and the United
Kingdom. The study is being funded in part by an $8.7 million grant
from the European Horizon 2020 Program.
“Hip fracture surgeries often result in serious
ongoing complications, including pain, disability, functional
decline and even death, and there are currently no treatments
approved for the post-operative regeneration of injured skeletal
muscle,” said Dr. Tobias Winkler, at the Berlin-Brandenburg Center
for Regenerative Therapies, Julius Wolff Institute and Center for
Musculoskeletal Surgery, and principal investigator of the Phase
I/II and Phase III studies. “The published study is the first to
successfully show the potential of an allogeneic cell therapy in
treating patients with skeletal muscle injury, and we eagerly await
data from the ongoing Phase III study as this promising therapy
advances towards commercialization.”
"The ongoing Phase III study has been precisely
designed based on the results of the published Phase I/II study,”
added Dr. Winkler. “Based on our results of a reduction of
postoperative stress by PLX-PAD, the indication has been adapted to
hip fracture patients, who suffer even more due to the
surgery-induced stress of hip arthroplasty. In addition, we
included in the Phase III study endpoints which measure the
systemic effect of PLX-PAD, which we observed in the earlier study,
such as increase of contralateral gluteal muscle force and
pro-regenerative immunological changes. Taken together, we believe
the Phase III study design greatly supports the likelihood of its
success.”
The data published also supports PLX-PAD
potential in treating additional muscle injuries. “The observations
on postoperative stress reduction indicate that using PLX-PAD cells
in cases where perioperative stress is highly relevant, such as in
sports injuries, traumatic muscle injuries, rotator cuff injuries
and other surgical approach related injuries, in spine or knee
surgeries, could lead to better outcomes in these patient groups,”
states Dr. Winkler. “In addition, since hip fracture patients
suffer widely from a condition of general muscle loss, called
sarcopenia, leading to frailty and a reduction of mobility, we
expect the data from the Phase III study to support the potential
use of PLX-PAD in these patients as well. We believe that the Phase
III study design will allow us to identify treatment parameters for
both acute muscle injuries as well as general muscle loss.”
“The two-year follow-up data from our Phase I/II
study demonstrate once again the safety and efficacy of PLX-PAD
cell therapy product and further suggest that PLX-PAD is a highly
versatile cell therapy with potential utility in multiple
indications,” said Yaky Yanay, Co-CEO and president of Pluristem.
“We continue to advance our Phase III programs and plan to open
additional clinical sites in Europe to advance the recruitment of
patients. The incidence of hip fracture is expected to
increase markedly as the global population ages, and we believe
PLX-PAD has the potential to significantly improve outcomes for
patients in need of a novel treatment option following
surgery.”
The Phase I/II study was a randomized, double
blind, placebo controlled study conducted at the Charité
Universitätsmedizin Berlin jointly with the Berlin- Brandenburg
Center for Regenerative Therapies and the Julius Wolff Institute
under the auspices of the Paul-Ehrlich Institute (PEI), Germany's
health authority. The injured muscle studied was the gluteus medius
muscle, which is intentionally cut during total hip arthroplasty.
20 patients were randomized into one of three cohorts: 150 million
cell dose of PLX-PAD, 300 million cell dose of PLX-PAD or placebo.
PLX-PAD or placebo was administered directly to the injured gluteus
medius muscle during surgery. The primary efficacy endpoint was the
change in the strength of the gluteus medius muscle six months
after surgery. The key secondary endpoint was the change in the
muscle volume of the gluteus medius six months after surgery, as
measured by MRI. The results of the study showed that PLX-PAD
demonstrated significant muscle regeneration including a highly
significant improvement in muscle volume (p=0.004) and muscle force
(p=0.0067) when observed six months after surgery compared to the
control group.
A copy of the Journal of Cachexia, Sarcopenia
and Muscle paper can be found here.
About Hip FractureFemoral neck
fracture is the most common form of hip fracture, with mortality
rates of up to 36%, and annual treatment costs estimated to be
between $10-$15 billion in the U.S. alone. Following surgery, many
patients do not fully recover due to poor muscle regeneration,
leading to significant morbidity, loss of the ability to live
independently, and an overall decline in quality of life. The
incidence of hip fracture is expected to increase as the population
ages.
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy products. The Company has reported robust clinical study
data in multiple indications for its patented PLX cells and is
entering late stage studies 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 it
discusses its belief that its PLX-PAD therapy is advancing toward
commercialization, its belief that the Phase III study design
greatly supports the likelihood of success of the Phase III study,
its belief that the published data supports PLX-PAD’s potential in
treating additional muscle injuries, its expectation that the data
from the Phase III study will support the potential use of PLX-PAD
in patients with sarcopenia, its plan to open additional clinical
sites in Europe with respect to its Phase III programs and its
believe that PLX-PAD has the potential to significantly improve
outcomes for patients in need of a novel treatment option following
surgery. 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 studies; 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 studies; 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 KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Karine Kleinhaus, MD, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
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