BrainStorm Granted Additional Patent for NurOwn® in Israel
January 22 2019 - 8:40AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for
debilitating neurodegenerative diseases, today announced that the
Israel Patent Office has granted an additional patent titled
“Methods of Generating Mesenchymal Stem Cells which Secrete
Neurotrophic Factors.” The allowed claims cover the method of
manufacturing the cells, the cells generated according to the
method of manufacturing, and the use of the cells for preparation
of a therapy for treating a disease (including a neurodegenerative
disease, a neurological and an immune disease).
“Our intellectual property estate for NurOwn®
technology platform continues to grow substantially as evidenced by
this new patent granted by the Israel Patent Office which is a
welcome addition to our IP portfolio. This patent covers NurOwn
(MSC-NTF cells) and its manufacturing process developed by
Brainstorm's scientists as well as the use of NurOwn for the
treatment of neurodegenerative diseases, an acute unmet need”
commented BrainStorm's CEO Chaim Lebovits. “Having an
Israel patented product and manufacturing process will increase our
ability to treat patients in desperate need of options for these
debilitating diseases in Israel. We expect that additional patents
owned or licensed exclusively by BrainStorm will be awarded this
year and in future years, thereby broadening the utility of NurOwn
in global markets across the world."
About NurOwn®
NurOwn® (autologous MSC-NTF) cells are an
innovative cellular technology platform that targets disease
pathways known to be important in neurodegenerative disorders.
MSC-NTF cells are produced from autologous, bone marrow-derived
mesenchymal stem cells (MSCs) that have been expanded and
differentiated under patented and scalable manufacturing processes
that induce the cells to secrete high levels of neurotrophic
factors and immunomodulatory cytokines. Autologous MSC-NTF cells
can effectively deliver these factors directly to the site of
damage to elicit a desired biological effect and ultimately slow or
stabilize disease progression. BrainStorm is actively enrolling a
Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment
of amyotrophic lateral sclerosis (ALS) (NCT03280056). BrainStorm
also recently received U.S. FDA acceptance to initiate a Phase 2
open-label multicenter trial in progressive Multiple Sclerosis (MS)
and plans to start enrollment in early 2019 (NCT03799718).
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 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 is
currently enrolling a Phase 3 pivotal trial in ALS, investigating
repeat intrathecal 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. For more information, visit
BrainStorm's website at www.brainstorm-cell.com.
Safe-Harbor Statements
Statements in this announcement other than
historical data and information 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, risks associated
with BrainStorm's limited operating history, history of losses;
minimal working capital, dependence on its license to Ramot's
technology; ability to adequately protect the technology;
dependence on key executives and on its scientific consultants;
ability to obtain required regulatory approvals; 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
Media:Joseph PetrozielloBrainStorm Cell TherapeuticsPhone:
+1.215.485.6797Email: JP@brainstorm-cell.com
Investors:Marcy Beth NanusSolebury TroutPhone:
+1.646.378.2927Email: MNanus@troutgroup.com
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