BrainStorm Cell Therapeutics Presentations at Neuromuscular Drug Development Summit
October 23 2019 - 1:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the
development of innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, will be participating and
presenting scientific data at the upcoming Neuromuscular Drug
Development Summit, from October 23-25th, in Boston MA. The
Summit is dedicated to solving the challenges in developing second
generation neuromuscular therapeutics.
BrainStorm’s team will be leading the following
sessions:
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Neuromuscular Drug Development
Summit: |
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1. Workshop A |
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Title: |
Effectively Using Neuromuscular
Biomarkers in Clinical Trials |
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Speaker: |
Susan Ward PhD, Head of Clinical
Operations, Brainstorm Cell Therapeutics Inc. |
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Date: |
Wednesday, 23 October 2019 |
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Time: |
0900-1200 |
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2. Navigating Clinical Trial
Design Complications for Neuromuscular Disorders |
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Title: |
How to Create Exclusion Criteria
& Characterize Patient Populations Whilst Maintaining Patient
Enrolment Quantity Through Phases |
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Speaker: |
Ralph Kern MD, MHSc, Chief
Operating and Chief Medical Officer, Brainstorm Cell
Therapeutics. |
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Date: |
Thursday, 24 October 2019 |
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Time: |
1500-1530 |
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3. FDA Approval – Is This
Therapeutic Success? |
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Panel Discussion: |
Assessment of Approval
Considerations |
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Speaker: |
Ralph Kern MD, MHSc, Chief
Operating and Chief Medical Officer, Brainstorm Cell
Therapeutics. |
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Date: |
Friday, 25 October 2019 |
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Time:
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1515-1545 |
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“Our participation at this important scientific
congress confirms our long-standing commitment to to advance
clinical trial design and biomarker development in ALS and to
develop practical drug approval strategies for patients affected by
ALS and other neuromuscular disorders,” said Ralph Kern MD, MHSc,
Chief Operating and Chief Medical Officer, Brainstorm.
“Brainstorm’s dedicated clinical and scientific
teams are focused on advancing our understanding of
neurodegenerative disease and how our innovative cell therapies may
bring much needed solutions to patients suffering from these
conditions,” said Chaim Lebovits, Brainstorm President and CEO, “We
are very privileged to collaborate with leading medical researchers
and scientists to advance our mission to quickly advance innovative
treatment options.”
About NurOwn® NurOwn® (autologous MSC-NTF cells)
represent a promising investigational 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. NurOwn® is
currently being evaluated in a Phase 3 ALS randomized
placebo-controlled trial and in a Phase 2 open-label multicenter
trial in Progressive MS.
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® Cellular Therapeutic 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 the 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 BLA filing
for U.S. FDA approval of autologous MSC-NTF cells in ALS.
BrainStorm received U.S. FDA clearance to initiate a Phase 2
open-label multi-center trial of repeat intrathecal dosing of
MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in
December 2018 and has been enrolling clinical trial participants
since March 2019. For more information, visit the company's
website.
Safe-Harbor
Statements
Statements in this announcement other than historical data
and information, including statements regarding future clinical
trial enrollment and data, 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,
BrainStorm’s need to raise additional capital, BrainStorm’s ability
to continue as a going concern, regulatory approval of BrainStorm’s
NurOwn® treatment candidate, the success of BrainStorm’s product
development programs and research, regulatory and personnel issues,
development of a global market for our services, the ability to
secure and maintain research institutions to conduct our clinical
trials, the ability to generate significant revenue, the ability of
BrainStorm’s NurOwn® treatment candidate to achieve broad
acceptance as a treatment option for ALS or other neurodegenerative
diseases, BrainStorm’s ability to manufacture and commercialize the
NurOwn® treatment candidate, obtaining patents that provide
meaningful protection, competition and market developments,
BrainStorm’s ability to protect our intellectual property from
infringement by third parties, heath reform legislation, demand for
our services, currency exchange rates and product liability claims
and litigation,; 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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