Pluristem Announces DMC Recommendation Following Interim Analysis of its Phase III CLI Study
December 09 2020 - 4:00AM
Pluristem Therapeutics Inc.
(Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological therapeutic products,
today announced that the independent Data Monitoring Committee
(DMC) of its global pivotal Phase III study for the treatment of
critical limb ischemia (CLI) issued its recommendation letter
following the interim analysis. The clinical dataset was reviewed
by the independent DMC for safety and analysis of the primary
endpoint of amputation-free survival, defined as time to occurrence
of major amputation of the index leg or death.
Based on the review, the DMC concluded that the
CLI study is unlikely to meet the primary endpoint by the time of
the final analysis. The DMC advised the Company that the CLI study
population has experienced a substantial low number of events
(major amputation of the index leg or death), different from what
is known in clinical medicine for the rate of these events in this
patient population. The lower than anticipated event rate in the
placebo group reduced the statistical power of the study to meet
its primary endpoint.
DMC noted that PLX-PAD was well tolerated, and
no significant safety concerns were raised during the study.
Following the DMC’s recommendation, the Company
decided to terminate the CLI study. Currently, the Company
continues to be blinded to the CLI study clinical data.
“We are deeply disappointed by the outcome of
the CLI interim analysis. In light of the DMC’s recommendation, we
decided that it would be in the best interests of the Company and
its shareholders to terminate the CLI study and focus our resources
and efforts on our other lead indications,” stated Pluristem CEO
and President, Yaky Yanay.
“We expect to present topline clinical results
during calendar year 2021, including our Phase III study in muscle
regeneration following hip fracture, Phase II studies in Acute
Respiratory Distress Syndrome (ARDS) associated with COVID-19 and
our Phase I study in incomplete hematopoietic recovery following
hematopoietic cell transplantation (HCT). Pluristem is well
positioned to advance and support future development of these
indications.”
“Throughout the years, we have developed unique
and propriety expertise, knowhow and intellectual property,
alongside a diverse clinical pipeline and we possess a
state-of-the-art cell manufacturing facility. We believe our
platform and technology will be a meaningful force in regenerative
medicine in a variety of therapeutic areas,” Mr. Yanay
concluded.
The Company will host a conference call on
December 9, 2020 at 8:30AM ET / 3:30PM Israel time. It can be
accessed via:
https://webcasting.brrmedia.co.uk/broadcast/5fc769bd2ac82b2af52e277b
About
Pluristem TherapeuticsPluristem
Therapeutics Inc. is a leading regenerative medicine company
developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple
indications for its patented PLX cell product candidates and is
currently conducting late stage clinical trials in several
indications. PLX cell product candidates are believed to 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; a Company-owned and operated
GMP-certified manufacturing and research facility; 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 that it expects
topline clinical results during the calendar year 2021 with respect
to its Phase III study in muscle regeneration following hip
fracture, its Phase II studies in ARDS associated with COVID-19 and
its Phase I study in incomplete hematopoietic recovery following
HCT, its belief that it is well positioned to support the future
development of these indications and its belief that its platform
and technology will be a meaningful force in regenerative medicine
in a variety of therapeutic areas. 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:Dana RubinDirector of Investor
Relations972-74-7107194danar@pluristem.com
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Sep 2023 to Sep 2024