Pluristem Expands its Phase II COVID-19 European Clinical Trial to Israel
October 07 2020 - 02:00AM
Pluristem Therapeutics Inc.
(Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological therapeutic products,
announced today that it has received approval from the Israeli
Ministry of Health to commence patient enrollment in Israel for the
Company’s COVID-19 Phase II clinical trial, under the protocol that
was approved by the Paul Ehrlich Institute (PEI), Germany’s
regulatory agency. A total of 40 patients hospitalized with severe
COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS)
will be enrolled at clinical sites in Israel and Germany.
The Phase II COVID-19 European clinical trial
that is being expanded to Israel is in addition to Pluristem’s
other COVID-19 clinical programs, including a Phase II study and an
Expanded Access Program in the U.S., both under the U.S. Food and
Drug Administration’s (FDA) approved protocol, and a per-patient
compassionate use program in Israel.
The primary efficacy endpoint of the Phase II
European study titled, “A Randomized, Controlled, Multicenter,
Parallel-Group Phase II Study to Evaluate the Efficacy and Safety
of Intramuscular Injections of PLXPAD for the Treatment of severe
COVID-19” is the number of ventilator free days during the 28 days
from day 1 through to day 28 of the study. Safety and survival
follow-up will be conducted up to week 52.
“We believe that the approval from the Israeli
Ministry of Health will enable us to advance the treatment of
severe COVID-19 patients. As the pandemic continues in Israel, we
see it as our mission to treat those severe patients in need. With
our broad COVID-19 clinical programs in Europe and the U.S., we are
committed to advancing our research and developing a treatment that
may help save lives,” stated Pluristem CEO and President Yaky
Yanay.
PLX Cells for COVID-19 PLX
cells are available off-the-shelf and once commercialized, can be
manufactured in large scale quantities, which we believe offers a
key advantage in addressing a global pandemic. PLX cells are
allogeneic mesenchymal-like cells that have immunomodulatory
properties that induce the immune system’s natural regulatory T
cells and M2 macrophages, and thus may potentially reverse the
dangerous overactivation of the immune system. Accordingly, PLX
cells may potentially reduce the severity of COVID-19 pneumonia,
leading hopefully to a better prognosis for the patients. Previous
pre-clinical findings of PLX cells revealed therapeutic benefit in
animal studies of pulmonary hypertension, lung fibrosis, acute
kidney injury and gastrointestinal injury which are potential
complications of the severe COVID-19 infection. Clinical data using
PLX cells demonstrated the strong immunomodulatory potency of PLX
cells in patients post major surgery. Initial clinical data on
COVID-19 ICU patients, treated under a Compassionate Use Program,
at the conclusion of a 28 day follow up were previously published.
Taken together, PLX cells’ potential capabilities with the safety
profile observed from clinical trials involving hundreds of
patients worldwide potentially position them as a therapy for
mitigating the tissue-damaging effects of COVID-19.
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 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 proposed
study in Israel, its belief that the approval from the Israeli
Ministry of Health will enable it to advance the treatment of
severe COVID-19 patients, its belief that the ability to
manufacture PLX cells in large scale quantities offers a key
advantage in addressing a global pandemic, the potential of PLX
cells in preventing or reversing the dangerous overactivation of
the immune system, that PLX cells may potentially reduce the fatal
symptoms of COVID-19 induced pneumonia, and PLX cells’ position as
a therapy for mitigating the tissue-damaging effects of
COVID-19.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 Feb 2024 to Mar 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Mar 2023 to Mar 2024