BrainStorm Announces First Contracted U.S. Clinical Site for Phase 2 Progressive MS Study
February 22 2019 - 7:30AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, announced today Cleveland
Clinic as the first U.S. clinical site contracted for a planned
Phase 2 open-label, multicenter study of repeated intrathecal
administration of autologous MSC-NTF cells in participants with
progressive Multiple Sclerosis (MS). The Phase 2 study
(NCT03799718) will enroll progressive MS patients [Expanded
Disability Status Scale (EDSS) 3.0-6.5] based on 2017 revised
McDonald Criteria.
MS is a chronic neuroinflammatory and
neurodegenerative disorder that affects the brain and spinal cord.
MS affects approximately 1 million individuals in the U.S. and 2.5
million individuals worldwide. Approximately half of affected
individuals will eventually develop a progressive disease, which
may lead to increasing levels of motor, visual, and cognitive
functional impairment and disability.
“We are very excited to announce The Mellen
Center for MS Treatment and Research at Cleveland Clinic as the
first contracted U.S. clinical site for this very important Phase 2
progressive MS study that we plan to initiate in early 2019,” said
Chaim Lebovits, president and CEO of BrainStorm. “This is a crucial
step forward toward rapidly enrolling a Phase 2 study to evaluate
this innovative autologous cell therapy approach using our
NurOwn® technology platform in progressive MS
patients.”
“Progressive MS treatment options are limited
and do not directly address unmet need”, said Ralph Kern MD MHSc,
COO and CMO of BrainStorm, “This phase 2 clinical trial is an
important part of our commitment to bring a new treatment modality
and hope to MS patients”.
Cleveland Clinic is currently ranked as the No.
2 hospital in the country, according to U.S. News & World
Report (2017-2018). The Mellen Center for Multiple Sclerosis
Treatment and Research at Cleveland Clinic is one of the largest
and most comprehensive programs for MS care and clinical research
worldwide, managing over 8,000 patients and over 21,000 total
visits annually.
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 plans to start enrollment in early 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 (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. For
more information, visit BrainStorm's website
at www.brainstorm-cell.com.
About Progressive Multiple SclerosisMS is an
inflammatory disorder in which infection-fighting white blood cells
enter the nervous system and cause injury. MS is a demyelinating
disorder because the myelin sheath that protects nerves is stripped
off during inflammation. Progressive MS is defined by the gradual
accumulation of neurological disability independent of relapses,
typically with lack of or incomplete recovery. Therapies utilizing
regenerative medicine and repair approaches may offer an innovative
treatment option. Autologous MSC-NTF cells are bone-marrow derived
mesenchymal stem cells (MSCs) propagated and differentiated in
culture to secrete high levels of neurotrophic factors (MSC-NTF).
In preclinical models, there is increasing recognition that NTFs
delivered by autologous MSCs have the potential for
immunomodulation, remyelination, and neuroprotection in progressive
MS. The Phase 2 study of autologous MSC-NTF cells in patients with
progressive MS (NCT03799718) will begin enrollment in early
2019.
Safe-Harbor
Statements Statements
in this announcement other than historical data and information
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, risks associated with BrainStorm's
limited operating history, history of losses; minimal working
capital, dependence on its license to Ramot's technology; ability
to adequately protect the technology; dependence on key executives
and on its scientific consultants; ability to obtain required
regulatory approvals; 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.
CONTACTSMedia: Sean Leous Westwicke/ICR PR
Phone: +1.646.677.1839 Email: sean.leous@icrinc.com
Investors: Marcy Beth Nanus Solebury Trout Phone:
+1.646.378.2927 Email: MNanus@troutgroup.com
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