NEW YORK, Sept. 16, 2020 /PRNewswire/ -- Brainstorm
Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of
adult stem cell therapeutics for neurodegenerative diseases, today
announced that the Japanese Patent Office (JPO) has granted
Brainstorm's Japanese Patent, number: 6,753,887, titled: 'Methods
of Generating Mesenchymal Stem Cells which Secrete Neurotrophic
Factors'.
The allowed claims cover a method of generating cells which
secrete neurotrophic factors from human undifferentiated
mesenchymal stem cells (MSCs) derived from the bone marrow of a
single donor. The said neurotrophic factors includes: brain derived
neurotrophic factor (BDNF); glial derived neurotrophic factor
(GDNF); hepatocyte growth factor (HGF); and vascular endothelial
growth factor (VEGF).
Patent families protecting NurOwn® manufacturing have
been issued in the United States,
Japan, Europe, Hong-Kong and Israel.
"We are extremely pleased with the continued development of our
patent portfolio protecting our technology through strategic
intellectual property achievements. This new patent grant
from the Japanese Patent Office is an important addition to our IP
portfolio for the NurOwn® technology and is an important element of
our business strategy" commented Brainstorm's CEO Chaim
Lebovits.
David Setboun, PharmD MBA, EVP and Chief Operating Officer,
added: "Having our cell therapy product patented in Japan will increase our ability to enter into
new commercial partnerships for NurOwn® in Japan."
About NurOwn®
NurOwn® (autologous 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. 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. BrainStorm is
currently conducting a Phase 3 pivotal trial of autologous MSC-NTF
cells for the treatment of amyotrophic lateral sclerosis (ALS).
BrainStorm also recently received U.S. FDA acceptance to initiate a
Phase 2 open-label multicenter trial in progressive MS and
enrollment began 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 (U.S. FDA) and the European
Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled its
Phase 3 pivotal trial in ALS (NCT03280056), investigating
repeat-administration of autologous MSC-NTF cells at six sites in
the U.S., 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 received U.S. FDA clearance
to run a Phase 2 open-label multicenter trial in progressive
Multiple Sclerosis. 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
Statements
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, 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