BrainStorm Presents Poster at Consortium of Multiple Sclerosis Centers (CMSC) 33rd Annual Meeting
May 31 2019 - 12:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, yesterday, on World MS
Day, presented a poster of the Company’s “Phase 2 Open-Label,
Multicenter Study of Repeated Intrathecal Administration of
Autologous MSC-NTF cells in Progressive Multiple Sclerosis (MS)” at
the Annual Meeting of the Consortium of Multiple Sclerosis Centers,
in Seattle.
POSTER HIGHLIGHTS:
- Study Design: Open label, single-arm Phase 2 study, at 5 US MS
clinical centers.
- Study Population: 20 Progressive MS patients with Expanded
Disability Status Scale (EDSS) 3.0-6.5, based on the 2017 revised
McDonald Criteria.
- Primary Endpoint: To evaluate the safety and tolerability of 3
repeated intrathecal doses of NurOwn® (MSC-NTF cells).
- Secondary Endpoints: To evaluate the efficacy of MSC-NTF
cells using validated MS clinical outcome assessments as well as
paired CSF and blood biomarker analyses.
- Study Status: Enrollment and treatment has been initiated with
topline clinical data expected in the first half of 2020.
- Conclusion: This Phase 2 open label study was designed to
provide preliminary data on the safety and efficacy of repeated
intrathecal doses of MSC-NTF cells in progressive MS patients to
inform the design of a Phase 3 pivotal trial.
“Remembering that World MS Day is a global event
that raises awareness of the invisible symptoms of MS, we shared
the design of our Phase 2 clinical study during the Annual Meeting
of the Consortium of Multiple Sclerosis Centers," said Ralph Kern,
MD, MHSc, Chief Operating Officer and Chief Medical Officer of
BrainStorm. He added, "CMSC is the largest North American
gathering for healthcare professionals and researchers engaged in
MS care and we were pleased to share our investigational study
design with leading members of the MS medical community.”
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 Leous
Westwicke/ICR PR Phone: +1.646.677.1839
Email: sean.leous@icrinc.com
Investors: Michael Levitan Solebury Trout
+1.646.378.2920mlevitan@soleburytrout.com
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