Pluristem to Announce Top-Line Results of Its Multinational Phase II Intermittent Claudication Study on June 12, 2018
June 04 2018 - 6:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
that the top-line results of the company’s multinational Phase II
clinical trial of PLX-PAD cells in the treatment of Intermittent
Claudication (IC) will be released on June 12, 2018.
Pluristem's Phase II IC trial is evaluating the
safety and efficacy of PLX-PAD cells as compared to placebo in 172
patients with IC, Rutherford category 2-3. Enrollment took place at
30 clinical sites in the U.S., Germany, South Korea and Israel.
Patients received either two courses of 150 ×106 PLX-PAD cells, two
courses of 300 ×106 cells, two courses of placebo, or one course of
300 ×106 cells followed by placebo. In each of these study arms,
the two courses were given intramuscularly, 3 months apart. The
primary efficacy endpoint is the change in maximal walking distance
one year after the first administration. Other endpoints include
rate of revascularization and other hemodynamic and clinical
parameters.
IC is a subset of peripheral artery disease
(PAD). It is caused by obstruction to arterial flow in the legs and
is characterized by muscle pain, cramping, numbness or a sense of
fatigue, classically in the calf muscle, which occurs during
walking or similar exercise and is relieved by a period of rest.
Almost fifth of the population over the age of 65 has IC and as a
result of demographic changes in many developed countries, its
prevalence in the general population is likely to rise dramatically
over the next 20 years. PLX-PAD cells may offer a non-surgical
procedure that may contributed significantly to the quality of life
of PAD patients as well as provide additional treatment
possibilities to the angioplasty and vascular medical
communities.
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 its
discusses the expected date for the release of the results of its
Phase II clinical trial of PLX-PAD cells in the treatment of IC and
that PLX-PAD cells may offer a non-surgical procedure that may
contributed significantly to the quality of life of PAD patients as
well as provide additional treatment possibilities to the
angioplasty and vascular medical communities. 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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