NEW YORK, July 2, 2020 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem
cell therapies for neurodegenerative diseases, announced today that
final participant dosing has been administered in the Phase 3
pivotal trial of NurOwn® (MSC-NTF cells) in amyotrophic lateral
sclerosis (ALS). The trial enrolled approximately 200
participants, randomized 1:1 to receive three doses of MSC-NTF
cells or placebo, administered over four months. As
previously reported, the Company expects top-line data from the
trial to be available in the fourth quarter of 2020, consistent
with the timeline established upon trial enrollment.
"Completion of participant dosing in this clinical trial is an
important milestone and brings us a step closer to potentially
filing a Biologics License Application to make MSC-NTF cells
available to people with ALS," Chaim
Lebovits, CEO of BrainStorm stated. "I would like to thank
the investigators and their staff at the participating sites for
their clinical excellence, especially for enabling this trial to
complete on time in the middle of the ongoing COVID-19 pandemic. I
must also express my complete gratitude to the trial participants
and their loved ones who fully devoted themselves to the challenges
of bringing an investigational therapeutic forward. We look forward
to the data readout later in 2020."
The Phase 3 NurOwn trial is being conducted at six centers of
excellence: University of California,
Irvine; Cedars-Sinai Medical Center; California
Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical
School and Mayo Clinic.
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. With this press release, BrainStorm
has now fully enrolled a Phase 3 pivotal trial of autologous
MSC-NTF cells for the treatment of amyotrophic lateral sclerosis
(ALS). BrainStorm also recently received acceptance from the U.S.
Food and Drug Administration (FDA) to initiate a Phase 2 open-label
multicenter trial in progressive multiple sclerosis (MS) and
initiated enrollment in March
2019.
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 also
recently received U.S. FDA clearance to initiate a 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.
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CONTACTS
Investor Relations:
Preetam Shah, MBA, PhD
Chief Financial Officer
BrainStorm Cell Therapeutics Inc.
Phone: + 1.862.397.1860
pshah@brainstorm-cell.com
Media:
Paul Tyahla
SmithSolve
Phone: + 1.973.713.3768
Paul.tyahla@smithsolve.com
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SOURCE Brainstorm Cell Therapeutics Inc