Two BrainStorm Scientific Abstracts Accepted for Presentation at the 71st American Academy of Neurology Annual Meeting
March 28 2019 - 4:30AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, announced today that two
scientific abstracts have been accepted for presentation at the
71st American Academy of Neurology (AAN) Annual Meeting in
Philadelphia, PA, May 4-10, 2019.
“We are thrilled that the AAN has selected two
Brainstorm Scientific Abstracts for presentation at the 71st Annual
meeting,” stated, Chaim Lebovits, CEO of Brainstorm Cell
Therapeutics. He added, “We are honored to share our
commitment to ALS translational science to many of the most
distinguished international leaders in patient-centered neurologic
care. Having one of our abstracts selected for oral
presentation, during the “Emerging Science Session” underscores our
commitment to impactful medical research and to advancing
ground-breaking investigational treatments for unmet needs in
life-altering and often fatal, neurological diseases.”
“The scientific abstracts selected by the AAN
for presentation provide a detailed molecular genetics
characterization of neurotrophic factor production by
NurOwn® and further correlate cerebrospinal fluid
biomarkers with clinical improvement in the completed Phase 2 ALS
study,” said Ralph Kern MD MHSc, Brainstorm Chief Operating Officer
and Chief Medical Officer. He concluded, “These findings contribute
to our overall understanding of the mechanism of action of
NurOwn® and provide further evidence linking ALS
clinical outcomes to highly relevant disease biomarkers.”
Presentation details are as
follows: Title:
MODULATION OF CSF CASPASE-3 IN MSC-NTF CELLS (NUROWN®) IN A
PHASE 2 ALS STUDY: CORRELATIONS WITH CSF BIOMARKERS AND CLINICAL
RESPONSE
Date: Tuesday, May 7, 2019
Time: 12:15 p.m.: Oral data blitz –
Emerging Science Session and 12:20 p.m. – 12:45 p.m.: Poster
Presentation.
Title: MOLECULAR CHARACTERIZATION
OF VEGF SECRETION BY MSC-NTF CELLS (NUROWN®): THERAPEUTIC
IMPLICATIONS IN ALS
Date: Thursday, May 9, 2019
Time: 11:30 a.m. – 6:30 p.m.: Poster
Session P5.
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. 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.brainstormcell.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) 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.
CONTACTS
Corporate: Uri Yablonka Chief Business Officer
BrainStorm Cell Therapeutics Inc. Phone: +1 646.666.3188
uri@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR PR Phone:
+1.646.677.1839 sean.leous@icrinc.com
Investors: Michael Levitan Solebury Trout
Phone:+1.646.378.2920 mlevitan@soleburytrout.com
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