BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society
November 14 2019 - 7:00AM
BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today that the Company has received a $495,330
grant from the National Multiple Sclerosis Society, through its
Fast Forward program, to advance BrainStorm’s Phase 2 open-label,
multicenter clinical trial of repeated intrathecal administration
of NurOwn® (autologous MSC-NTF cells) in participants with
progressive Multiple Sclerosis (NCT03799718).
Chaim Lebovits, President and CEO of BrainStorm
stated, “We are very pleased to receive this generous grant from
the National MS Society. Currently, we are conducting our Phase 2
study in three leading US medical centers: The Keck School of
Medicine of USC, The Stanford School of Medicine, and Cleveland
Clinic. This research funding will help advance our
investigational therapy NurOwn as a potential unmet need for
patients with progressive MS. MS continues to devastate the lives
of patients and their families and we thank the National MS Society
for helping us advance our innovative research program.”
“Currently, progressive MS treatment options are
limited and NurOwn is a promising new autologous cellular treatment
modality that has the potential to directly address MS disease
pathways,” said Ralph Kern MD MHSc, COO and CMO of BrainStorm. He
added, “This funding from the National MS Society will help us
explore key neuroinflammation and neural repair biomarkers in
progressive MS to confirm NurOwn’s unique mechanism of action and
guide the design of future clinical trials to address this
important unmet patient need.”
”Leveraging resources in this Phase 2 clinical
study of a cell-based therapy for progressive MS exemplifies our
work to accelerate research to improve clinical care for people
living with MS.” said Mark Allegretta, PhD, Vice President of
Research at the National MS Society. “We’re pleased to work with
BrainStorm to test a broad panel of biomarkers of neuroinflammation
and repair as correlates of the effect of treatment with
NurOwn®”.About Multiple SclerosisMultiple sclerosis is an
unpredictable, often disabling disease of the central nervous
system. There is currently no cure for MS. Symptoms vary from
person to person and range from numbness and tingling, to mobility
challenges, blindness and paralysis. An estimated 1 million people
live with MS in the United States. Most people are diagnosed
between the ages of 20 and 50 and it affects women three times more
than men.
About The National Multiple Sclerosis
Society:The National MS Society, founded in 1946, funds
cutting-edge research, drives change through advocacy, and provides
programs and services to help people affected by MS live their best
lives. Connect to learn more and get involved:
nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or
1-800-344-4867.
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 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 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 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. 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
Corporate: Uri
Yablonka Chief Business Officer BrainStorm Cell
Therapeutics Inc. Phone: 646-666-3188
uri@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR
PR Phone: +1.646.677.1839 sean.leous@icrinc.com
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