BrainStorm Announces the Mount Sinai Medical Center as a Progressive MS Phase 2 Clinical Trial Site
November 25 2019 - 6:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, today announced that The
Mount Sinai Medical Center, internationally acclaimed for its
excellence in research, patient care, and education in multiple
sclerosis and across a range of medical specialties, has contracted
with BrainStorm as a clinical study site for the Company’s Phase 2
open-label, multicenter study of repeated intrathecal
administration of NurOwn® (autologous MSC-NTF cells) in
participants with progressive Multiple Sclerosis (MS)
(NCT03799718).
“Internationally recognized Multiple Sclerosis
expert Fred Lublin, MD, will serve as the Principal Investigator at
the Mount Sinai Medical Center,” said Chaim Lebovits, President and
CEO of BrainStorm. He added, “The Corinne Goldsmith Dickinson
Center for Multiple Sclerosis at Mount Sinai is a leading center in
MS research and discovery and we are ready to enroll patients under
the supervision of Dr. Lublin and his highly experienced clinical
team.”
“BrainStorm looks forward to partnering with and
supporting Dr. Lublin and the dedicated clinical trial team at the
Mount Sinai Hospital to quickly advance the phase 2 progressive MS
clinical trial,” said BrainStorm Chief Operating Officer and Chief
Medical Officer, Ralph Kern MD MHSc.
“We are happy to be a part of this exciting
study to determine if neurally-directed stem cells can be a
therapeutic approach to treating MS,” said Dr. Lublin.
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 has
fully enrolled 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 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. Dr. Lublin and several leading MS experts
previously served as consultants to Brainstorm in the initial study
conception and design. 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.comMedia:Sean
LeousWestwicke/ICR PR Phone:
+1.646.677.1839sean.leous@icrinc.com
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