BrainStorm Announces First Patient Enrolled in Phase 2 Clinical Trial of Progressive MS
March 14 2019 - 1:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, announced today that the
first patient has been enrolled in its Phase 2 open-label,
multicenter study of repeated intrathecal administration of
autologous MSC-NTF cells in participants with progressive Multiple
Sclerosis (MS).
Chaim Lebovits, president and CEO of BrainStorm
stated, “Midway through MS Awareness Week: March 10-16, we are
pleased to announce the first participant with progressive MS has
been enrolled in our Phase 2 clinical trial. Progressive MS has
deeply affected the lives of many and dramatically impacted family
members, caregivers and others. Today, there is no U.S. FDA
approved therapy addressing more than one progressive form of MS
and we are pleased to deploy our NurOwn® technology platform in
this new indication. Soon, we will announce additional sites where
the clinical trials will be conducted.”
“The first participant enrolled in our Phase 2
trial represents an important milestone in our commitment to
address the unmet medical need in progressive MS,” said Ralph Kern,
MD MHSc, Chief Operating and Chief Medical Officer of
Brainstorm. “We plan to quickly initiate enrollment across
all study sites and look toward top line data by the middle of
2020.”
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 form of the
disease, which may lead to increased levels of motor, visual, and
cognitive functional impairment and disability.
For more information, refer to
www.clinicaltrials.gov, using the NCT identifier (NCT03799718).
About NurOwn® Technology Platform
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 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 Sclerosis
MS 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) started enrollment in March
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:Michael LevitanSolebury
Trout+1.646.378.2920mlevitan@soleburytrout.com
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