Pluristem Reports Positive Top-Line Results from Its Multinational Phase II Intermittent Claudication Study
June 12 2018 - 6:00AM
PLX-PAD treatment reduced risk of
revascularization and improved patients’ mobility. Study
validates the design of Pluristem’s ongoing Pivotal Phase III study
in Critical Limb Ischemia (CLI)
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
positive top-line results from its multinational Phase II clinical
study of PLX-PAD cells in the treatment of Intermittent
Claudication (IC). PLX-PAD treatment reduced Incidence of
revascularization and improved patients’ mobility. Study results
also validate the design of Pluristem’s ongoing Pivotal Phase III
study in CLI, a more severe stage of peripheral arterial disease
(PAD) and confirm Pluristem’s proprietary Bio-Therapeutic approach.
Pluristem's Phase II IC study was designed to
evaluate the safety, efficacy and optimal dosing regimen for
PLX-PAD cells in patients with IC, Rutherford categories 2-3.
Enrollment took place at 28 clinical sites in the U.S., Germany,
South Korea and Israel. The 172 patients in the study were
randomized into four treatment groups: two administrations of 300
million PLX-PAD cells (“main efficacy group”); two administrations
of 150 million PLX-PAD cells; two administrations of placebo; or
one administration of 300 million PLX-PAD cells followed by
placebo. In each of these study arms, the two administrations were
given intramuscularly (IM), 3 months apart. The primary efficacy
endpoint was the change from baseline in maximal walking distance
(MWD) at 52 weeks compared to placebo. The key secondary endpoint
was the change from baseline in MWD at 52 weeks compared to
placebo, in patients treated with 2 doses of PLX-PAD originating
from different placentas (Pluristem’s proprietary Bio-Therapeutic
approach). Other endpoints included risk of revascularization and
other hemodynamic and clinical outcome measures.
Top Line Results:
- Patients treated with 2 administrations of 300 million PLX-PAD
cells showed statistically significant improvement (p=0.0008) in
MWD as compared to baseline at 52 weeks.
- Key primary efficacy endpoint, improvement in MWD as compared
to placebo, in analysis by country, showed best results with
statistically significant improvement (effect size= 51.1%, p=0.015)
in U.S patients (n=73) treated with 2 administrations of 300
million PLX-PAD cells.
- Key secondary efficacy endpoint, improvement in MWD following
administration of 2 doses of 300 million PLX-PAD cells originating
from different placentas, showed statistically significant
improvement at 52 weeks (effect size= 42.0%, p=0.043) as compared
to placebo. These patients also demonstrated a statistically
significant improvement (effect size= 83%, p=0.0007) in MWD at 52
weeks as compared to baseline.
- Revascularization risk was reduced by 49% (Hazard ratio = 0.51)
in the main efficacy group at week 65. Patients receiving 2
administrations of PLX-PAD cells originating from different
placentas were “revasc-free” (no revascularization events) at week
65.
- IM administration of PLX-PAD cells was safe and well
tolerated.
Validation of study design in ongoing Pivotal Phase III
study in Critical Limb Ischemia (CLI):
- Dose confirmation- Study results demonstrated dose of 300
million PLX-PAD cells as the optimal dose for treatment of PAD
- Two administrations of 300 million PLX-PAD cells demonstrated a
statistically significant superior effect (p=0.0331) compared to a
single administration of 300 million PLX-PAD cells in MWD at week
52, suggesting that in chronic indications such as PAD a second
treatment may be required to significantly improve the clinical
outcome.
- Pluristem’s proprietary Bio-Therapeutic approach of using cells
originating from different placentas for each administration, as
implemented in the CLI pivotal Phase III clinical study, was shown
to generate a superior therapeutic effect.
“We are highly encouraged by the results seen in
the study. The option of treating peripheral artery diseases like
IC and CLI through IM injections of PLX-PAD cells is promising, and
an important outcome, demonstrating the potential ability to
implement regenerative medicine advanced technologies in
cardiovascular diseases. We look forward to the CLI pivotal study
results that may demonstrate the ability of Pluristem’s cell
therapy to improve patient outcomes and create economic benefits
for the healthcare systems,” stated Dr. Manesh Patel, Chief of the
Division of Cardiology at Duke University Health System, and the
lead principle investigator (PI) for the U.S. Phase II IC
study.
“These promising results demonstrate a
clinically meaningful treatment effect. Finding a non-surgical
medical solution for PAD, especially in patients who are unsuitable
for revascularization, has proven to be one of the biggest medical
challenges in recent years. These study results are highly
encouraging and suggest that PLX-PAD cells may be the answer for
both PAD patients and physicians seeking effective medical
solutions,” commented Prof. Norbert Weiss, MD, Director of the
Vascular Center at the Technical University of Dresden, Germany,
and the lead PI for the European Phase II IC study.
“We are very pleased with the study results that
may bring hope to millions of patients worldwide suffering from
peripheral artery diseases,” stated Pluristem Chairman and Co-CEO
Zami Aberman. “These results suggest that PLX-PAD cells may be
efficacious in the treatment of PAD and could significantly reduce
the need for invasive procedures in these patients. Furthermore,
these results provide important validation to our ongoing pivotal
Phase III study in CLI in terms of dose selection, dual-dosing
administration regimen and the superiority of our proprietary
Bio-Therapeutic approach we have developed in the last few years of
using different placentas when more than one treatment is required.
The unique PLX platform and manufacturing processes we developed
enable us to confirm donor-to-donor and batch-to-batch
comparability and achieve optimal clinical benefits.”
About Peripheral Artery Diseases (PAD)
Peripheral Arterial Disease (PAD) is caused by
fatty deposits in leg arteries that obstruct blood flow. Risk
factors include smoking, diabetes, heavy weight, cardiovascular
problems and hypertension. An earlier stage of PAD is Intermittent
Claudication (IC) with symptoms of leg pain and weakness brought on
by exercise, with resolution of the symptoms following rest. IC can
progress to Critical Limb Ischemia (CLI) when patients suffer from
severe pain at rest, skin wounds, tissue necrosis and poor quality
of life with a high risk of leg amputation and death. PAD affects
4-12% of people aged 55-70 years and 15-20% of people aged over 70
years. The frequency of lower extremity artery disease is strongly
age-related, rising steeply after 50 years of age. PAD afflicts
about 20 million U.S. citizens, 28 million Western Europeans and 42
to 60 million Chinese citizens.
Pluristem’s Phase III study in Critical Limb
Ischemia (CLI), was cleared by the U.S Food and Drug Administration
(FDA) and European Medicines Agency (EMA) and is recruiting
patients (n=246) in the U.S. and Europe.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of 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 its
discusses the potential outcome of the IC study’s impact on its CLI
study, including dosage administration, that the study result may
bring hope to millions of patients worldwide suffering from
peripheral artery diseases and that the study results suggest that
PLX-PAD cells may be efficacious in the treatment of PAD and could
significantly reduce the need for invasive procedures in these
patients. 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
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Apr 2023 to Apr 2024