BrainStorm Cell Therapeutics to Present Late Breaking News ePoster at the 35th ECTRIMS Congress
September 06 2019 - 01:50AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the
development of innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, will present scientific
data at the 35th Congress of the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS,
www.ectrims-congress.eu), September 11-13th in Stockholm, Sweden.
BrainStorm is conducting a Phase 2 open-label,
US-based, multicenter study of repeated intrathecal administration
of NurOwn® in participants with Progressive Multiple Sclerosis. The
Phase 2 study will evaluate validated MS efficacy outcome measures
as well as innovative and validated CSF and serum biomarkers. The
efficacy outcome data presented at this ECTRIMS meeting provides a
natural history cohort matched to the phase 2 patient population.
The phase 2 MS study is actively enrolling participants and should
be fully enrolled by early 2020.
Ralph Kern, MD, MHSc, Chief Operating Officer
and Chief Medical Officer of BrainStorm said, “We are very pleased
to have the opportunity to participate at ECTRIMS, the largest
annual International Congress devoted to basic and clinical
research in Multiple Sclerosis (MS). The BrainStorm team
looks forward to meeting with many of the leading scientists in MS
and sharing our ideas with the many researchers who are dedicated
to changing the lives of those with MS.”
Meeting and Presentation
Details:
|
ECTRIMS Late Breaking News ePoster: |
|
Title: Disability improvement assessed by
multiple sclerosis functional composite in progressive MS patients
from the CLIMB Study |
|
Authors: T. Chitnis, M. Rosso, H. Yano, B.
Glanz, M.C. Manieri, R. Kern, S. Ward, M. Mehra, H. Weiner, B.
Healy, Brigham and Women's Hospital, Ann Romney Center for
Neurologic Diseases and Massachusetts General Hospital, Boston,
MA, BrainStorm Cell Therapeutics, NY, NY. |
|
Session: Poster Session 3 |
|
Date: Friday, 13 September 2019 |
|
Time: 12:15-14:15 |
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. 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
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