BrainStorm Announces Notice of US Patent Allowance for NurOwn® Cellular Therapeutic Technology Platform
October 07 2019 - 8:04AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapeutics for neurodegenerative
diseases, today announced that the United States Patent and
Trademark Office (USPTO) has issued a Notice of Allowance for
BrainStorm's new US Patent Application, number: 15/113,105, titled:
‘Method of Qualifying Cells'.
The allowed claims cover a pharmaceutical
composition for MSC-NTF cells secreting neurotrophic factors
(NurOwn®) comprising a culture medium as a carrier and an isolated
population of differentiated bone marrow-derived MSCs that secrete
neurotrophic factors.
Patent families protecting NurOwn® have
previously issued in the United States, Japan, Europe, Hong-Kong
and Israel.
"This allowance further expands the patent
protection of the NurOwn® Cellular Therapeutic Technology Platform
and enables us to accelerate clinical development for new
neurodegenerative indications,” commented BrainStorm President and
CEO, Chaim Lebovits.
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 is currently enrolling a
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 recently received U.S. FDA
clearance to initiate 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 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
Corporate: Uri Yablonka Chief Business Officer
BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188
uri@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR PR Phone:
+1.646.677.1839 sean.leous@icrinc.com
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