NEW YORK, July 1, 2020 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem
cell therapies for neurodegenerative diseases, will hold a Key
Opinion Leader (KOL) webinar on the Company's Alzheimer's disease
(AD) clinical program on Wednesday July
8th at 8.15am ET.
The Company recently announced that it is expanding its clinical
pipeline to develop NurOwn® in AD.
The webinar will feature presentations by the two lead
investigators in BrainStorm's planned international Phase 2 trial
in AD: Philip Scheltens, M.D.,
Ph.D., Professor of Cognitive Neurology and Director of the
Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of
Neurology at the Neurological Institute of the Salpétrière
University Hospital in Paris,
France. The 52-week, open-label, proof-of-concept clinical
trial is designed to evaluate NurOwn® in 40 participants with
prodromal to mild AD. It will be conducted at VU University Medical
Center (Amsterdam),
Pitié-Salpêtrière Hospital (Paris), and several other clinical trial
sites in the Netherlands and
France.
Philip Scheltens, M.D.,
Ph.D. received both his M.D. degree (1984) and his
Ph.D. in Magnetic Resonance Imaging in Alzheimer's Disease (1993)
from VU University in Amsterdam.
His main clinical and research interests are Alzheimer's disease,
vascular dementia, frontotemporal dementia, magnetic resonance
imaging, PET imaging and fluid biomarkers. He has been the
national principal investigator (PI) for over 35 studies, including
several Phase 1-3 multicenter clinical trials. Dr. Scheltens
founded the Alzheimer Centere at VU University in 2000, and
co-founded and assumed the chairmanship of the board of Deltaplan
Dementie, the Dutch national plan against dementia, in 2013. He is
also the co-editor-in-chief of Alzheimer's Research & Therapy,
one of the leading journals in this field.
Dr. Scheltens has authored more than 1,000 peer-reviewed papers
and more than 75 book chapters. He co-edited books
on Magnetic Resonance in Dementia and Neuroimaging
in Dementia (Springer) as well as Functional Magnetic
Resonance Imaging: Clinical Applications (Oxford University Press). In 2011, he was elected
to the Royal Dutch Academy of Arts and Sciences (KNAW) and served
as Secretary General until 2020. In 2016 he was awarded the
European Grand Prix for Alzheimer's Research. He is co-leading
and participating in various European Union (EU) projects,
including the Innovative Medicines Initiative projects on European
Prevention of Alzheimer's Dementia (IMI-EPAD), the Amyloid Imaging
to Prevent Alzheimer's Disease (IMI-AMYPAD), the European Medical
Information Framework for Alzheimer's Disease (EMIF-AD) and Remote
Assessment of Disease and Relapse in Alzheimer's Disease
(RADAR-AD).
Bruno Dubois, M.D.,
Ph.D., is Professor of Neurology at the University
Salpêtrière Hospital in Paris,
Sorbonne-University and Director of the Institute for Memory and
Alzheimer Disease (IM2A). He also directs the Expert Memory Center
Paris-Sud and the Research INSERM Unit on Cognition and
Neuroimaging in Brain Diseases at the Institut du Cerveau et de la
Moelle épinière (ICM, Brain and Spine Institute) in Paris. He is Coordinator of the National
Reference Centers for Rare Dementias and Young-Onset Alzheimer
Disease and of the Paris Center of Excellence in Neurodegeneration
(CoEN). Dr. Dubois has published more than 600 peer-reviewed
articles on anatomical and biochemical studies of the central
cholinergic systems in rodents and humans, as well as on cognition
in patients with dementia, with special focus on memory, executive
functions and frontal lobe behaviors, and biomarkers in
neurodegenerative disorders. He leads an international working
group of experts (IWG) on the new criteria for Alzheimer disease.
He is principal or co-investigator of several research programs
focusing on AD, prodromal AD, and dementia in Parkinson's disease
as well as the EU Joint Programme on Neurodegenerative Disease
(JPND), IMI-EPAD and IMI- AMYPAD. Dr. Dubois is President of the
French Society of Neurology and a member of the National Academy of
Medicine.
Webcast Information
The webinar will take place on July 8,
2020 at 8:15 AM ET. The presentation will be followed by
a question-and-answer session with Professors Scheltens and Dubois
and with BrainStorm management.
Register for Call/Webinar Here
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 (NTFs). 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 has fully enrolled a Phase 3 pivotal trial of autologous
MSC-NTF cells for the treatment of amyotrophic lateral sclerosis
(ALS). BrainStorm also recently received acceptance from the U.S.
Food and Drug Administration (FDA) to initiate a Phase 2 open-label
multicenter trial in progressive multiple sclerosis (MS) and
initiated enrollment 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 (FDA) and the European Medicines Agency (EMA)
for the treatment of amyotrophic lateral sclerosis (ALS).
BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS
(NCT03280056), investigating repeat-administration of autologous
MSC-NTF cells at six U.S. sites 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
(MS). 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 Statement
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
Investor Relations:
Preetam
Shah, MBA, PhD
Chief Financial Officer
BrainStorm Cell Therapeutics Inc.
Phone: + 1.862.397.1860
pshah@brainstorm-cell.com
Media:
Paul Tyahla
SmithSolve
Phone: + 1.973.713.3768
Paul.tyahla@smithsolve.com
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SOURCE Brainstorm Cell Therapeutics Inc