BrainStorm Cell Therapeutics to Present NurOwn® Phase 2 Biomarker Data at North East Amyotrophic Lateral Sclerosis (NEALS) 1...
October 02 2019 - 6:45AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the
development of innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases announced today, Chief
Operating Officer and Chief Medical Officer, Ralph Kern, MD, MHSc,
will present NurOwn® Phase 2 biomarker data at the 18th Annual
NEALS Meeting held October 2-4, 2019 in Clearwater, Florida.
In addition, Dr. Kern will represent BrainStorm at the NEALS
member/industry partner roundtable that will discuss the evolving
landscape of ALS clinical trials and potential surrogate and
functional endpoints for regulatory approval.
Chaim Lebovits, President and CEO of BrainStorm,
said, “BrainStorm is pleased that Dr. Kern will be presenting our
innovative CSF surrogate biomarker data at NEALS. On September
23rd, the FDA issued a new ALS therapy development guidance
document emphasizing the importance of biomarkers for the
advancement of ALS investigational therapies. We are pleased to
have the opportunity to present our ongoing research to clinical
leaders who are at the forefront of ALS investigation and
scientific discovery.”
Meeting and Presentation
Details:
|
|
|
|
|
NEALS Poster Presentation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Title: |
|
|
|
CSF MCP-1, a surrogate biomarker for ALS (Poster 73) |
|
|
|
|
|
Presenter: |
|
|
|
Ralph Kern, MD, MHSc, BrainStorm Cell Therapeutics, NY,
NY. |
|
|
|
|
|
Date: |
|
|
|
Thursday October 3, 2019 |
|
|
|
|
|
Time: |
|
|
|
4-5 pm |
|
|
|
|
|
|
|
|
|
|
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
TherapeuticsBrainStorm 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. BrainStorm also recently 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, 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
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Apr 2023 to Apr 2024