Pluristem Initiates Two Pivotal Phase III Studies in Israel
August 08 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a
leading developer of placenta-based cell therapy products,
announced today that Israel’s Ministry of Health has cleared the
Company to commence patient recruitment in Israel for two ongoing
pivotal Phase III trials of PLX-PAD cell therapy, one for the
treatment of Critical Limb Ischemia (CLI) and another for the
treatment of muscle injury following hip fracture surgery. Both
trials have been accepted to accelerated approval pathways and have
received a total of $16.7 million in grants from the European
Union’s Horizon 2020 Program.
“We are pleased to open clinical sites in Israel
for both of our ongoing pivotal Phase III studies. These sites may
enable Pluristem to apply for marketing approval in Israel for both
indications, aligning with potential regulatory approvals in the
U.S. and Europe and expedite the completion of recruitment of both
pivotal trials,” stated Pluristem Chairman and Co-CEO, Zami
Aberman.
Pluristem’s pivotal Phase III study of PLX-PAD
cells in the treatment of CLI, which has received an $8 million
grant from the European Union’s Horizon 2020 program, and is
currently recruiting patients in the U.S., U.K., Germany, Poland,
Czech Republic, Hungary, Bulgaria and Macedonia. PLX-PAD has
received the U.S. Food and Drug Administration’s (FDA) Fast Track
designation for the treatment of CLI and has been included in the
European Medicines Agency (EMA) Adaptive Pathways program, which
may lead to early conditional marketing authorization based on an
interim analysis following treatment of half of the total 246
patients to be enrolled in the study. The FDA recently cleared
PLX-PAD for its Expanded Access Program (EAP) for the treatment of
patients with CLI who are not eligible for Pluristem’s Phase III
study. 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.
Pluristem’s pivotal Phase III study in the
treatment of muscle injury following arthroplasty for hip fracture
was awarded an $8.7 million grant by the European Horizon 2020
Program. This study will recruit 240 patients through clinical
sites in the U.S., Europe and Israel.
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. 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 intent to apply for marketing approval for CLI and
treatment of muscle injury following hip fracture surgery, the
potential for Pluristem to obtain early conditional marketing
authorization from the FDA and EMA relating to its PLX-PAD cells
and its description of the recruitment and timing of its studies.
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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