U.S. FDA Clears Pluristem’s Phase III Study in Treatment of Muscle Injury Following Hip Fracture Surgery
April 25 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that the U.S. Food and Drug Administration (FDA) has cleared
Pluristem’s Investigational Drug Application (IND) for a Phase III
study of its PLX-PAD cell therapy in the treatment of muscle injury
following surgical repair (arthroplasty) of the hip joint due to
fracture. Pluristem is in discussions with several EU countries to
approve this study in Europe as well and expects to begin patient
enrollment in both regions during 2018. Non-dilutive funding
totaling $8.7 million (7.4 million Euro) has been granted to this
study from Horizon 2020, the European Union’s largest research and
innovation program.
The Phase III study follows positive results
from a Phase I/II trial which demonstrated significant muscle
regeneration when using PLX-PAD cells in total hip arthroplasty
patients. The study demonstrated a 300% change in muscle volume
(p=0.004) and a 500% (p=0.0067) change in muscle force at 6 months
post-surgery, compared to the control group.
The Phase III, multinational, randomized,
double-blind, placebo-controlled study will assess the efficacy and
safety of intramuscular (IM) administration of allogeneic PLX-PAD
cells for the treatment of muscle injury following arthroplasty for
hip fracture, as compared to placebo treatment. Through clinical
sites in the U.S. and Europe, 240 patients will be randomized on a
1:1 allocation to be dosed with 150 million PLX-PAD cells or
placebo on the day of surgery. The primary endpoint is the change
in the short physical performance battery (SPPB) score at week 26
after treatment.
“The FDA’s clearance marks the second Phase III
study for Pluristem in the U.S. for our PLX-PAD cell therapy and we
look forward to begin patient enrollment in 2018,” stated
Pluristem’s President and Co-CEO, Yaky Yanay. “We are encouraged by
our prior Phase I/II study results that showed PLX-PAD supported
muscle regeneration and we are hopeful that PLX-PAD will be
similarly effective for patients in our Phase III study. I am
pleased to see the successful execution of our clinical development
plan with a series of Phase III multinational studies, which we
believe positions Pluristem as one of the most advanced and mature
companies in the regenerative medicine industry.”
Dr. Tobias Winkler of the Berlin-Brandenburg
Center for Regenerative Therapies, Julius Wolff Institute and
Center for Musculoskeletal Surgery, the principal investigator of
the study, commented, “We look forward to evaluating PLX-PAD’s
ability to aid muscle regeneration in patients recovering from
arthroplasty for hip fracture. Following surgery, many patients do
not fully recover and suffer considerable morbidity due to poor
muscle regeneration and impaired mobility. If the results of the
study show efficacy, then one simple procedure administering an IM
dose of PLX-PAD on the day of surgery may significantly reduce
recovery time and recovery costs, while improving quality of life
for these patients.”
About Hip Fracture
Femoral 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 populations age.
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 cells and is entering late-stage trials in several
indications. Our 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 its Phase III clinical trial of PLX-PAD cells generally
as well as its expectation that it will begin patient enrollment in
the U.S. and Europe in 2018, its belief that the successful
execution of its clinical development plan with a series of Phase
III multinational studies positions Pluristem as one of the most
advanced and mature companies in the regenerative medicine industry
and the possibility that PLX-PAD may significantly reduce recovery
time and recovery costs and improve quality of life. 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, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Apr 2023 to Apr 2024