BrainStorm Announces Second Clinical Site to Enroll Patients in Its Progressive MS Phase 2 Study
30 May 2019 - 3:00PM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, today announced that the
Stanford University School of Medicine will serve as the second
contracted clinical study site 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).
“I am especially pleased, we are able to
announce the BrainStorm medical team continues to advance our Phase
2 clinical study in progressive MS on the World MS Day, a day set
aside to raise awareness of the invisible symptoms of MS,” said
Chaim Lebovits, president and CEO of BrainStorm. “Conducting
clinical studies at top-tier US medical institutions will ensure
that our FDA-approved clinical studies meet the highest scientific
standards. The addition of study participants at the Stanford
University School of Medicine with those who have received dosing
at other clinical sites, brings us one step closer to our objective
of advancing NurOwn® as an investigational therapy to address unmet
need in progressive MS.”
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. 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:Sean LeousWestwicke/ICR PR Phone:
+1.646.677.1839Email: sean.leous@icrinc.com
Investors:Michael LevitanSolebury
Trout+1.646.378.2920mlevitan@soleburytrout.com
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