Pluristem Receives Positive Feedback from FDA and EMA as Company Prepares for Phase III Trial of PLX-PAD to Support Recovery ...
September 26 2017 - 7:00AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, has today
reported the status of its planned Phase III hip fracture study. In
previous discussions held with the U.S. Food and Drug
Administration (FDA) and the European Medicine Agency (EMA), the
company received positive feedback on the proposed study design and
endpoints of its Phase III trial in PLX-PAD cells as a treatment
for muscle recovery following arthroplasty for hip fracture. This
trial was recently awarded an $8.7 million grant by the Horizon
2020 program, the European Union’s largest research and innovation
program.
The proposed Phase III trial is intended to
support marketing authorization and will be a double-blind,
randomized, placebo-controlled trial with approximately 180
patients enrolled in clinical sites across the U.S. and Europe.
Patients will be injected intramuscularly with 150 million PLX-PAD
cells during arthroplasty for hip fracture. The primary endpoint
for the trial will be the change of Short Physical Performance
Battery (SPPB) from baseline to six months after surgery.
Additional endpoints may include objective measurements of muscle
strength and muscle volume.
This Phase III trial follows positive results
from a Phase I/II trial which demonstrated significant muscle
regeneration when PLX-PAD cells were injected 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.
“Now that this Phase III trial has been awarded
$8.7 million from the Horizon program, we are eager to move forward
and are extremely pleased by the positive outlook of these key
regulatory bodies regarding our proposed study design and
endpoints, which we believe may allow for early recognition of
performance improvement in patients,” noted Zami Aberman, Chairman
and Co-CEO of Pluristem. “With this positive feedback from the FDA
and EMA, we believe that this trial will again yield significant
results, offering new hope for the thousands of patients around the
world who have difficulty healing from hip surgeries due to poor
muscle recovery.”
Pluristem plans to submit the Investigational
New Drug (IND) and Clinical Trial Application (CTA) for the trial
in the coming months. The company plans to use the results of this
Phase III trial to achieve regulatory approval in both the U.S. and
Europe. Pluristem’s PLX-PAD program is one of only a handful to be
accepted into Europe’s Adaptive Pathway program, which may also
allow for early marketing approval in Europe.
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 (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 timing and format of the proposed Phase III study,
that the proposed Phase III trial is intended to support marketing
authorization, that the proposed endpoints of the proposed Phase
III trial may allow for early recognition of performance
improvement in patients, that Pluristem believes that the proposed
Phase III trial will yield significant results, that Pluristem
plans to submit the IND and CTA for the proposed Phase III trial in
the coming months and that Pluristem plans to use the results of
the proposed Phase III trial to achieve regulatory approval in both
the U.S. and Europe. 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
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