NEW YORK, June 24, 2020 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem
cell therapies for neurodegenerative diseases, today announced a
new clinical program focused on the development of
NurOwn® as a treatment for Alzheimer's disease. As part
of the newly announced program, the Company is planning a
multi-national Phase 2 clinical trial to evaluate the safety and
efficacy of NurOwn treatment in patients with prodromal to mild
Alzheimer's disease.
"Our newly announced Alzheimer's program is an important
strategic expansion of BrainStorm's clinical pipeline," said
Chaim Lebovits, Chief Executive
Officer of BrainStorm. "We see this as an ideal complement to our
lead amyotrophic lateral sclerosis (ALS) program, as there are
compelling data suggesting that the benefits observed with NurOwn
in ALS patients may extend to other neurological conditions,
including Alzheimer's disease. As we move towards completion of our
pivotal Phase 3 ALS study, the newly announced Alzheimer's program,
combined with our ongoing progressive multiple sclerosis (MS)
program, will continue to drive the advancement of the
NurOwn platform. Through the completion of our clinical trial
programs, BrainStorm hopes to advance NurOwn to address unmet needs
across a broad population of patients with neurodegenerative
disease."
The lead investigators of the trial are two world renowned
clinical experts in Alzheimer's disease, Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D. Prof. Scheltens, the
principal investigator (PI) of the study, is Professor of Cognitive
Neurology and Director of the Alzheimer Centre at Amsterdam
University Medical Centers. He has extensive experience as PI of
many international clinical trials in this field. Prof. Dubois, the
French national coordinator of the study, is Professor of Neurology
at the Neurological Institute of the Salpétrière University
Hospital. He is President of the Scientific Committee of
France-Alzheimer and of IFRAD (International Fund Raising for
Alzheimer's Disease) as well as a member of the European Alzheimer
Disease Consortium (EADC). Profs. Scheltens and Dubois will discuss
the proposed clinical trial during an upcoming Key Opinion Leader
(KOL) webinar and call hosted by BrainStorm on July 8, 2020 at 8:15 AM
ET.
Speaking on the trial Prof. Scheltens stated, "We are very eager
to evaluate the efficacy of NurOwn in the treatment of
Alzheimer's disease, because of its unique mechanism of action.
While many previous Alzheimer's therapies have focused on a single
target such as tau or beta-amyloid, NurOwn has the capability to
simultaneously target multiple relevant biological pathways and
bring a comprehensive approach to this multifactorial disease.
Importantly, NurOwn's mechanism of action may also allow the
therapy to enable synergistic combinations with anti-tau or
anti-beta-amyloid treatments, further underscoring its potential to
address critical unmet needs in Alzheimer's disease."
Prof. Dubois added, "In such a complex disease, addressing
inflammation and neuro-protection is an innovative and very
interesting approach. It is a first in the world for this
technology and Brainstorm is leveraging encouraging results from
the Phase 2 study in ALS."
Ralph Kern, M.D., MHSc.,
President and Chief Medical Officer of BrainStorm, noted, "In the
proposed Phase 2 clinical trial, our goal is to confirm that the
potential shown by NurOwn in our lead ALS program may be extended
to patients with Alzheimer's disease. We now have a compelling set
of biomarker data supporting NurOwn's mechanism of action,
including important pharmacodynamic changes in cerebrospinal fluid
(CSF) inflammatory mediators. Additionally, our innovative
biomarker-driven precision medicine approach, which will focus on
patients with early-stage disease and pre-defined levels of CSF tau
and beta-amyloid proteins, may greatly facilitate Phase 2 clinical
trial success."
Stacy Lindborg, Ph.D., Executive
Vice President and Head of Global Clinical Research at BrainStorm,
said, "We are excited to introduce a novel approach to Alzheimer's
disease that targets both inflammation as well as neurotrophic
factors. Given the acute need for vastly different treatment
methodologies, we believe our broad targeting approach, combined
with robust effects on CSF measures and a favorable safety profile,
allows us to go forward with confidence. Additionally, compiling
NurOwn safety data across diseases will allow us to enhance patient
safety for each trial."
Phase 2 Trial to be Conducted at Leading Alzheimer's disease
Centers in Europe
BrainStorm plans to conduct a 52-week, Phase 2 open-label,
proof-of-concept clinical trial to evaluate NurOwn in 40
participants with prodromal to mild Alzheimer's disease. Study
participants will receive three intrathecal NurOwn doses 8 weeks
apart. In addition to meeting well-defined clinical criteria for
prodromal to mild Alzheimer's disease, participants must also meet
biomarker defined criteria for Alzheimer's disease. The clinical
trial will evaluate safety and pharmacodynamics of NurOwn,
including effects on inflammatory, Alzheimer's-specific,
neurodegenerative, and synaptic biomarkers, as well as a range of
key clinical measures of cognition and function. The clinical trial
will be conducted at the Brain research Center affiliated with the
Alzheimer Center Amsterdam, Pitié-Salpêtrière Hospital
(Paris), and several other
clinical trial sites in the
Netherlands and France.
NurOwn is protected by patents granted in the United States, Europe, Israel, and elsewhere covering treatments of
neurodegenerative diseases, including Alzheimer's disease.
These include European patent no. EP2620493B1 (Mesenchymal stem
cells for the treatment of CNS diseases).
Key Opinion Leader Call and Webcast
BrainStorm will host a call and webinar featuring Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D., on July 8, 2020 at 8:15 AM
ET. The webinar will be followed by a question-and-answer
session with Professors Scheltens and Dubois.
Dial-in and Webcast Information
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.
Logo -
https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
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
View original
content:http://www.prnewswire.com/news-releases/brainstorm-expands-clinical-pipeline-to-evaluate-nurown-for-the-treatment-of-alzheimers-disease-301082711.html
SOURCE Brainstorm Cell Therapeutics Inc