WASHINGTON, June 9, 2020 /PRNewswire/ -- The ALS Association
and I AM ALS announced today that the organizations have awarded a
combined grant of $500,000 to
BrainStorm Cell Therapeutics (NASDAQ: BCLI), a biotechnology
company, to support an amyotrophic lateral sclerosis (ALS)
biomarker research study. The grant will be used to draw insights
from data and samples collected from patients enrolled in
BrainStorm's ongoing phase 3 clinical trial of its NurOwn®
treatment, to further understanding of critical biomarkers
associated with treatment response for people with ALS.
The study is designed to evaluate how NurOwn interacts with its
targets in the brain and spinal cord and to explore the changes in
the biomarkers that may correlate with response to the drug
treatment. Biomarkers are any measurable substance in the body that
change over time (such as cholesterol or blood pressure) and that
correlate with disease processes or treatment response. If
successful, this study will help confirm that the ALS treatment
NurOwn works in the way it is intended and will help inform our
larger understanding of ALS biomarkers.
"This grant to BrainStorm marks an important step forward in
establishing how exactly NurOwn works in the body," said Calaneet
Balas, President and CEO of The ALS Association. "This research is
also important to our overall pursuit of identification and
validation of ALS biomarkers. We hope NurOwn is ultimately proven
effective in treating ALS and we stand ready to support BrainStorm
in its plan to apply for a biologics license for NurOwn."
Danielle Carnival, CEO of I AM ALS commented, "We need to move
with urgency in all of our efforts to deliver treatments and cures
for ALS. This biomarker research will help us more expeditiously
understand the effectiveness of NurOwn, while possibly unlocking
discoveries that provide clues for other promising treatments. We
are at a pivotal time for ALS research in pursuit of treatment
solutions and will do whatever we can, together, to drive new
answers and new hope for patients."
The joint award to BrainStorm consists of a $400,000 grant from The ALS Association and a
$100,000 grant from I AM ALS. As part
of this agreement, BrainStorm has agreed to share data and samples
with the ALS community so that the results can be independently
validated and to advance other ALS research.
Chaim Lebovits, CEO of BrainStorm
stated, "We sincerely appreciate the scientific recognition and
generous support from The ALS Association and I AM ALS and we are
excited through this study to further an already strong partnership
between The ALS Association, I AM ALS and Brainstorm. This critical
research study involves one of the largest and most robust clinical
trial collections of CSF biomarkers. Data generated from this study
will increase our understanding of how NurOwn® therapy impacts ALS
disease progression and may identify patients who benefit the most
from this form of therapy. We also hope that this research study
will benefit the broader ALS scientific community as we
collectively advance towards our shared goal of delivering much
needed treatments."
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 The ALS Association
The ALS Association is the largest private funder of ALS
research in the world. The Association funds global research
collaborations, provides assistance for people with ALS and their
families through our nationwide network of chapters and certified
clinical care centers, and advocates for better public policies for
people with ALS. The ALS Association builds hope and enhances
quality of life while urgently searching for new treatments and a
cure. For more information about The ALS Association, visit our
website at www.als.org.
About I AM ALS
Founded in 2019 by husband-wife team Brian Wallach and Sandra
Abrevaya, I AM ALS was born out of their desire to change
the future for Brian and the thousands of other ALS patients in the
world. I AM ALS brings together patients, advocates, organizations
and scientists to deliver critical and innovative resources for
patients, empower and mobilize patients and their networks to lead
the fight for cures, and transform the public understanding of ALS
with a goal of flooding the research pipeline with new, lifesaving
drugs. A cure is possible ... if we work together to re-imagine the
fight against ALS. Learn more here: www.iamals.org.
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
About ALS
ALS is a disease that attacks cells in the body that control
movement. It makes the brain stop talking to the muscles, causing
increased paralysis over time. Ultimately, ALS patients become
prisoners within their own bodies, unable to eat, breathe, or move
on their own. Their mind, however, often remains sharp so they are
aware of what's happening to them.
Contact: Brian
Frederick
The ALS Association
(202)
464-8612
bfrederick@alsa-national.org
Contact: Kathleen
Rooney
I AM ALS
(312)
529-0391
Kathleen@iamals.org
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SOURCE Brainstorm Cell Therapeutics Inc