FDA Clears Pluristem’s Expanded Access Program to Initiate Treatments of Critical Limb Ischemia Outside of Ongoing Phase II...
January 09 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 & Drug Administration (FDA) has cleared the
Company’s Expanded Access Program (EAP) for the use of its PLX-PAD
cell treatment in patients with Critical Limb Ischemia (CLI). EAP
allows the use of an investigational medical product outside of
clinical trials and is usually granted in cases where patients are
unsuitable for inclusion under the study protocol and the patient’s
condition is life-threatening with an unmet medical need.
As part of the program, Pluristem’s PLX-PAD cell
therapy will be made available to a limited number of Rutherford
Category 5 CLI patients in the U.S. who are unsuitable for
revascularization and cannot take part in the Company’s ongoing
Phase III clinical study, which is currently enrolling patients in
the U.S. and Europe. The Company’s PLX-PAD program has already been
selected for accelerated approval pathways in both regions,
including the FDA’s Fast Track Designation and the European
Medicines Agency’s (EMA) Adaptive Pathways program.
“This is a true vote of confidence by the FDA in
our cell therapy and a landmark achievement for Pluristem and its
shareholders. It gives us the ability to begin treatments using our
cell product, offering treatment to certain CLI patients who have
poor therapeutic options, while also collecting real-world data
alongside our ongoing Phase III clinical study,” said Yaky Yanay,
Co-CEO and President of Pluristem. “We are hopeful that the FDA may
also allow us to be compensated for the costs of treatment, which
can support our work developing effective cell therapies for
millions of patients worldwide.”
CLI is an advanced stage of peripheral artery
disease where fatty deposits block arteries in the legs, leading to
pain, non-healing ulcers, and gangrene. Patients with CLI have a
high risk of amputation and death, and those unsuitable for
revascularization are left with no adequate treatment options.
Pluristem’s PLX-PAD cell therapy utilizes placental cells to
secrete a range of therapeutic proteins that trigger the body’s own
repair mechanisms, allowing it to grow blood vessels, bring
oxygenated blood to damaged tissue, and heal itself faster.
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. 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 that its PLX-PAD cell therapy will be made available to a
limited number of Rutherford Category 5 CLI patients in the U.S.
and that the FDA may allow it to be compensated for the costs of
treatment, which can support the Pluristem’s work to develop
effective cell therapies for millions of patients worldwide. 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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