Fifth and Final Site Announced for BrainStorm’s Progressive Multiple Sclerosis Phase 2 Clinical Trial
February 27 2020 - 1:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, today announced that
Partners MS Center at Brigham and Women’s Hospital, a leading
research and clinical care center, 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).
“Tanuja Chitnis, MD, Director of the CLIMB
Natural History Study, which is assessing the disease course and
prognosis of approximately 2000 MS patients, will serve as the
Principal Investigator at Brigham and Women’s Hospital,”
said Chaim Lebovits, President and CEO of BrainStorm. He
added, “The Partners MS Center at Brigham and Women’s
Hospital provides comprehensive patient care, innovative
technology and ongoing clinical research trials. We’re excited to
have them join the trial, and we expect that they will soon enroll
participants under the supervision of Dr. Chitnis and her
highly experienced clinical team.”
Ralph Kern, MD, MHSc, Chief Operating and Chief
Medical Officer of BrainStorm added, “It has been less than a year
since we contracted with our first progressive MS clinical site,
half of the study participants have already been screened and 2
study participants have completed all study visits. We are very
privileged to have Dr. Chitnis and her team advance our clinical
study of NurOwn in progressive MS.”
“We are excited to participate in this research study, which
will allow us the opportunity to investigate potential new
therapies for our patients with progressive MS,” said Chitnis, who
is also a professor of Neurology at Harvard Medical School and a
senior neurologist at Brigham and Women's Hospital.
Tanuja Chitnis, MD, and the Partners MS Center
at The Brigham and Women’s Hospital team join the other top US MS
centers: Cleveland Clinic, Stanford University, School of Medicine,
Mount Sinai Medical Center and University of Southern California
for the Company’s Phase 2 open-label, multicenter study of repeated
intrathecal administration of autologous MSC-NTF cells in
participants with progressive Multiple Sclerosis (MS)
(NCT03799718).
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 repeat-dosing autologous MSC-NTF cells (NurOwn) for the
treatment of amyotrophic lateral sclerosis (ALS).
BrainStorm received U.S. FDA acceptance to
initiate a Phase 2 open-label multicenter repeat-dosing trial of
autologous MSC-NTF cells (NurOwn) in progressive MS and enrollment
began in March 2019. Currently half of the expected trial
participants are enrolled.
Top line results for both clinical trials are
expected in the fourth quarter of 2020.
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 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 LeousWestwicke/ICR PR Phone:
+1.646.677.1839sean.leous@icrinc.com
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