Pluristem Launches FDA-Cleared COVID-19 Expanded Access Program, Enabling Patient Treatment Outside of Clinical Trial
August 27 2020 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological therapeutic products,
announced today that the U.S. Food and Drug Administration (FDA)
has cleared the Company’s Expanded Access Program (EAP) for the use
of its PLX-PAD cells to treat Acute Respiratory Distress Syndrome
(ARDS) caused by COVID-19 outside of the Company’s ongoing Phase II
COVID-19 study in the U.S. The program provides a pathway for
patients that are not eligible for inclusion in the Phase II
clinical trial to be treated with PLX-PAD cells. The EAP will
include up to 100 patients, with the resulting data collected and
evaluated alongside Pluristem’s clinical trial.
“We are excited to offer expanded access to our
PLX-PAD cell therapy for patients in need who are suffering from
severe complications of COVID-19,” stated Pluristem CEO and
President, Yaky Yanay. “The FDA clearance of our EAP follows our
recent experience treating COVID-19 patients under compassionate
use programs in the U.S. and Israel, and, we believe emphasizes the
urgent medical need for new therapeutic options to treat COVID-19
patients who are critically ill. We believe that now is the time
for governments and states to ensure medical centers throughout the
United States can offer these crucial treatments on a large scale.
We, at Pluristem, are committed to harnessing our commercial-scale
manufacturing capabilities to deliver on these requirements and
make our novel PLX cells with favorable safety profiles available
to all in need.”
Alongside the EAP in the U.S., Pluristem will
continue to advance its two ongoing COVID-19 Phase II clinical
trials of its PLX-PAD product candidate for the treatment of severe
ARDS in the U.S. and Europe, and treat patients under the
compassionate use program in Israel.
PLX Cells for COVID-19PLX cells
are available off-the-shelf and once commercialized, can be
manufactured in large scale quantities, offering 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 prevent or reverse the dangerous
overactivation of the immune system. Accordingly, PLX cells may
potentially reduce the incidence and/or severity of COVID-19
pneumonia and pneumonitis 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. 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 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 will include
up to 100 patients in the EAP and that the resulting data will be
collected and evaluated alongside its clinical trial, its belief
that the approval of its EAP by the FDA emphasizes the urgent
medical need for new therapeutic options to treat COVID-19 patients
who are critically ill, the belief that now is the time for
governments and states to ensure medical centers throughout the
United States can offer crucial treatments on a large scale, its
commitment to harnessing its commercial-scale manufacturing
capabilities to deliver on these requirements and make its
novel PLX cells with favorable safety profiles available to all in
need, when it discusses the potential of PLX cells in preventing or
reversing the dangerous overactivation of the immune system, that
PLX cells may potentially reduce the incidence and/or severity of
COVID-19 pneumonia and pneumonitis leading hopefully to a better
prognosis for the patients, 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
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