New Findings from Pluristem’s Phase II IC study: PLX-PAD Cells Significantly Improves Blood Glucose Control (HbA1c) and Red...
November 12 2018 - 7:30AM
Additional data from Pluristem’s Phase II
IC study were presented at the 2018 American Heart Association
Scientific Sessions
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, today announced that the Company presented
additional data from its Phase II clinical study evaluating PLX-PAD
for the treatment of Intermittent Claudication (IC) at the 2018
American Heart Association Scientific Sessions in Chicago. The data
were presented by Prof. Norbert Weiss, MD, Director of the Vascular
Center at the Technical University of Dresden, Germany, and the
lead European Principal Investigator for the Phase II IC study.
Among the study findings:
- Additional analysis of the Phase II IC data confirmed the
optimal dosing regimen of PLX-PAD in the treatment of peripheral
arterial diseases (PAD) - two administrations of 300 million cells,
each originating from a different donor. This is also the treatment
regimen being administered to patients in the Company’s ongoing
multinational Phase III study in Critical Limb Ischemia (CLI), a
more severe stage of PAD.
- Patients treated with PLX-PAD at the optimal dosing regimen
showed statistically significant improvement (effect size=42.0%,
p=0.043) in maximum walking distance (MWD) at 52 weeks across all
sites (U.S, Europe, Israel and South Korea), nationalities, gender
and ethnicity as compared to placebo. These patients also
experienced no revascularization events at 65 weeks as compared to
12% occurrence in the placebo group.
- An additional analysis of the data showed patients treated with
PLX-PAD at the optimal dosing regimen demonstrated a significant
(p= 0.0012) decrease of 48% in C-reactive protein (CRP) at 65
weeks, as compared to 95% increase in the placebo group. High
levels of CRP, a protein found in blood plasma, is associated with
inflammation which is associated with PAD.
- Moreover, these patients also experienced a statistically
significant relative reduction of 7.77 (mmol/mol) in Hemoglobin A1C
(HbA1c) at 65 weeks compared to placebo (p=0.0155). HbA1c measures
the amount of blood sugar (glucose) attached to hemoglobin. A
reduction in HbA1c indicates better glucose control in patients and
is the most commonly used measurement to evaluate treatment
efficacy in diabetics.
- PLX-PAD treated patients showed good safety profile in the
study as well as a reduction in the incidence of adverse events
including malignancies, respiratory events and cardiac
disorders.
“We are very encouraged with the results and
additional findings seen in this study. PAD patients, especially
those suffering from CLI, often display high level of inflammation
and, as seen within our IC study, most are diabetic,” commented
Prof. Weiss. “The data we presented at the AHA suggest that PLX-PAD
may play a meaningful role in lowering inflammation and maintain
better glycemic control reflecting the potential of this
non-surgical cell-based therapeutic to address key unmet needs of
PAD and the associated co-morbidities.”
“This study was important in confirming the
design of our ongoing Phase III trial evaluating PLX-PAD for the
treatment of CLI, and we are optimistic that these promising
results will be reproducible in larger patient populations,” said
Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem.
“The recent findings provide comprehensive understanding of PLX-PAD
cells mechanism of action in PAD patients by supporting
angiogenesis, reducing inflammation and lowering the average
glucose levels of this patients. The recent FDA approval of the
expanded access program in CLI, together with the multiple special
regulatory pathways that we have been granted in the U.S. and
Europe, and the significant funding that we have received for this
project to date, justify our growing enthusiasm for PLX-PAD as a
potential new and groundbreaking treatment for PAD. We look forward
to Phase III data as we work to introduce this treatment as an
innovative solution for PAD patients.”
Initial topline results from this Phase II IC
study were previously announced by the Company in June
2018.
About Pluristem’s Phase II IC
StudyPluristem'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 donors (Pluristem’s proprietary Bio-Therapeutic
approach). Other endpoints included risk of revascularization and
other hemodynamic and clinical outcome measures.
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel 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 StatementThis 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 potential of
PLX-PAD to play a meaningful role in lowering levels of CRP and
HbA1c and to address key unmet needs of PAD, the ability to
reproduce the results of clinical trials in larger patient
populations and the potential for PLX-PAD to be a new and
groundbreaking treatment for PAD. 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.
Contact:
Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Karine Kleinhaus, MD, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
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