U.S. FDA Approves Cost Recovery for PLX-PAD under Expanded Access Program in the Treatment of Critical Limb Ischemia
October 16 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, and WideTrial Inc., a privately-held third-party
sponsor of authorized Expanded Access Programs (EAPs), today
announced that the parties have entered into agreement to initiate
an FDA-cleared EAP for Pluristem’s cell therapy product, PLX-PAD,
for the treatment of critical limb ischemia (CLI). The parties
further announced that the FDA has authorized WideTrial to charge
payment for the PLX-PAD EAP treatment. Under the terms of the EAP,
an initial 100 Rutherford-5 CLI patients who are ineligible for
inclusion under Pluristem’s ongoing Phase 3 study protocol, and
whose condition is life-threatening, will be enrolled.
“Patients suffering from critical limb ischemia
are often unsuitable for revascularization and therefore experience
poor clinical outcomes, including amputation. The condition can be
fatal if left untreated,” said Yaky Yanay, Co-CEO and President of
Pluristem. “We believe the FDA’s decision to approve this Expanded
Access Program with cost-recovery for this novel and potentially
life-saving cell therapy reflects the Agency’s comfort with the
safety profile of PLX-PAD, and recognition of its potential use in
treating CLI patients who have few remaining treatment options. As
we progress through the EAP, we look forward to generating valuable
real world data concurrent with our ongoing 246-patient Phase 3
study that we are currently enrolling in U.S., Europe and Israel.
Together, these clinical initiatives are expected to yield a
significant body of evidence that we believe will support the
safety and efficacy of PLX-PAD and may represent a significant
advancement in the treatment of CLI.”
“We are pleased to make PLX-PAD more widely
available to CLI patients in need while allowing Pluristem’s
management to stay focused on its ongoing Phase 3 clinical study,”
said Jess Rabourn, Chief Executive Officer of WideTrial. “Expanded
Access Programs allow pre-market treatment use of new medicines by
patients who suffer from severe conditions and who cannot enroll in
regular clinical studies. These programs can also generate real
world data from a wider range of patients in the target population,
insights from which could help inform further development of this
particular study drug.”
Pluristem’s PLX-PAD program has been selected
for accelerated approval pathways in both the U.S. and Europe,
including the FDA’s Fast Track Designation and the European
Medicines Agency’s (EMA) Adaptive Pathways program.
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,
particularly later stages of the disease (Rutherford Categories 5
and 6) 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 WideTrial
WideTrial is a third-party sponsor of
small-group and large-group Expanded Access programs for patients
who do not meet the enrollment criteria of traditional research
studies. The company uses its scalable platform to make
pre-market access more attractive to drug developers and to improve
the inclusiveness of the overall drug development
process.
About Pluristem
Therapeutics
Pluristem 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 the timing, description and parameters of its EAP with
Widetrial, its belief that the FDA’s approval of the EAP reflects
its comfort with the safety profile of PLX-PAD and may lead to
recognition of its potential use in treating CLI patients who have
few remaining treatment options and that the results of the EAP are
expected to yield a significant body of evidence that it believes
will support the safety and efficacy of PLX-PAD and may represent a
significant advancement in the treatment of CLI. 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 KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Karine Kleinhaus, MD, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
Ian Manger, PhD Director of Clinical Sciences WideTrial, Inc.
(415) 691-4556 ian.manger@widetrial.com
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