BrainStorm Announces Groundbreaking Pre-Clinical Study of NurOwn® derived Exosome-Based Treatment for COVID-19 ARDS
July 23 2020 - 7:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today that it has successfully completed its
first milestone in developing an innovative exosome-based
platform-technology for the treatment severe COVID-19 infection.
COVID-19 induced pneumonia carries a high
fatality rate and has been associated with acute respiratory
distress syndrome (ARDS). Currently, there is no effective
treatment strategy to prevent or reverse ARDS, a type of
respiratory failure associated with widespread inflammation and
lung damage mediated by dysregulated cytokine production. Exosomes
are nano-sized (30–150 nm) vesicles secreted by all cell types.
Mesenchymal stem cells (MSC) derived exosomes have been suggested
as a potential treatment for ARDS due to their ability to penetrate
into deep tissues, effectively deliver bioactive molecules to
target cells and mitigate the inflammatory response. MSC exosomes
may be delivered intravenously or directly into the lung via
intratracheal administration. Results from a study in a mouse model
of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal
administration of NurOwn® (MSC-NTF cells) derived exosomes resulted
in a statistically significant improvement in multiple lung
parameters. These included the clinically relevant factors:
functional lung recovery, reduction in pro-inflammatory cytokines
and most importantly, attenuation of lung damage. Moreover, MSC-NTF
cell derived exosomes exhibited a superior effect when compared to
treatment with exosomes derived from naïve mesenchymal stem cells
(MSC) from the same donor. BrainStorm intends to accelerate
submission of these important results to peer-reviewed medical
journals.
The preclinical experiment demonstrated a
statistically significant reduction in lung disease severity score
(p=0.03) (based on the American Thoracic Society Documents, 2011;
Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011)
and vastly improved lung histology following intratracheal
administration of NurOwn (MSC-NTF) exosomes compared to MSC
exosomes.
A graph accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/224bd3d0-90a3-4850-8b56-854d808c6386
An image accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/e5276300-106b-4a35-9ef5-7d8907561db9
To-date, BrainStorm Cell Therapeutics has
focused its clinical development on the application of the NurOwn
technology platform to neurodegenerative disorders. Given these
important pre-clinical results, the Company will revisit its
strategy to determine if and when to proceed with a clinical trial
in ARDS.
Dr. Revital Aricha, VP of Research &
Development at BrainStorm, will discuss the results on the
company’s second quarter 2020 earnings call and corporate update,
scheduled for Wednesday August 5th, at 8.00am ET.
About NurOwn®
The NurOwn technology platform (autologous
Mesenchymal stem cells, MSC-NTF cells) represent a promising
investigational therapeutic approach to targeting disease pathways
important in neurodegenerative disorders. MSC-NTF cells are
produced from autologous, bone marrow-derived mesenchymal stem
cells (MSCs) that have been expanded and differentiated ex vivo.
MSCs are converted into MSC-NTF cells by growing them under
patented conditions that induce the cells to secrete high levels of
neurotrophic factors (NTFs). Autologous MSC-NTF cells can
effectively deliver multiple NTFs and immunomodulatory cytokines
directly to the site of damage to elicit a desired biological
effect and ultimately slow or stabilize disease progression.
About BrainStorm Cell Therapeutics
Inc.
BrainStorm Cell Therapeutics Inc. is a leading
developer of innovative autologous adult stem cell therapeutics for
debilitating neurodegenerative diseases. The Company holds the
rights to clinical development and commercialization of the NurOwn
technology platform used to produce autologous MSC-NTF cells
through an exclusive, worldwide licensing agreement. Autologous
MSC-NTF cells have received Orphan Drug status designation from the
U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) for the treatment of amyotrophic lateral sclerosis
(ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS
(NCT03280056), investigating repeat-administration of autologous
MSC-NTF cells at six U.S. sites supported by a grant from the
California Institute for Regenerative Medicine (CIRM CLIN2-0989).
The pivotal study is intended to support a filing for U.S. FDA
approval of autologous MSC-NTF cells in ALS. BrainStorm is also
conducting a U.S. FDA approved Phase 2 open-label multicenter trial
in progressive multiple sclerosis (MS). The Phase 2 study of
autologous MSC-NTF cells in patients with progressive MS
(NCT03799718) started enrollment in March 2019. For more
information, visit the company's website at
www.brainstorm-cell.com
Safe-Harbor Statement
Statements in this announcement other than
historical data and information, including statements regarding
future clinical trial enrollment and data, constitute
"forward-looking statements" and involve risks and uncertainties
that could cause BrainStorm Cell Therapeutics Inc.'s actual results
to differ materially from those stated or implied by such
forward-looking statements. Terms and phrases such as "may",
"should", "would", "could", "will", "expect", "likely", "believe",
"plan", "estimate", "predict", "potential", and similar terms and
phrases are intended to identify these forward-looking statements.
The potential risks and uncertainties include, without limitation,
BrainStorm’s need to raise additional capital, BrainStorm’s ability
to continue as a going concern, regulatory approval of BrainStorm’s
NurOwn treatment candidate, the success of BrainStorm’s product
development programs and research, regulatory and personnel issues,
development of a global market for our services, the ability to
secure and maintain research institutions to conduct our clinical
trials, the ability to generate significant revenue, the ability of
BrainStorm’s NurOwn treatment candidate to achieve broad acceptance
as a treatment option for ALS or other neurodegenerative diseases,
BrainStorm’s ability to manufacture and commercialize the NurOwn
treatment candidate, obtaining patents that provide meaningful
protection, competition and market developments, BrainStorm’s
ability to protect our intellectual property from infringement by
third parties, heath reform legislation, demand for our services,
currency exchange rates and product liability claims and
litigation,; and other factors detailed in BrainStorm's annual
report on Form 10-K and quarterly reports on Form 10-Q available at
http://www.sec.gov. These factors should be considered carefully,
and readers should not place undue reliance on BrainStorm's
forward-looking statements. The forward-looking statements
contained in this press release are based on the beliefs,
expectations and opinions of management as of the date of this
press release. We do not assume any obligation to update
forward-looking statements to reflect actual results or assumptions
if circumstances or management's beliefs, expectations or opinions
should change, unless otherwise required by law. Although we
believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance or achievements.
CONTACTS
Investor Relations:Preetam Shah, MBA, PhDChief
Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: +
1.862.397.1860pshah@brainstorm-cell.com
Media:
Paul Tyahla SmithSolve Phone: + 1.973.713.3768
Paul.tyahla@smithsolve.com
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Apr 2023 to Apr 2024