BrainStorm Presents New Data Highlighting NurOwn® Immunomodulation in Neurology
May 04 2020 - 3:30AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell technologies for neurodegenerative
diseases, today announced that new data highlighting the
immunomodulatory effects of NurOwn® on B and T regulatory function
appeared in an online supplement to Neurology.
The abstract was originally planned for
presentation at the recently cancelled 2020 American Academy of
Neurology (AAN) annual meeting. In addition to the online
supplement, the abstract is also available through the AAN
online abstracts website.
“Neuroinflammation is a prominent pathological
feature of ALS and progressive MS. Reduced T and B regulatory
function may contribute to disease progression, and lower IL-10
levels may be associated with reduced ALS function and with higher
disability and MRI lesion load in secondary progressive MS,” said
Ralph Kern MD, MHSc, President and Chief Medical Officer of
Brainstorm, “The immunomodulatory properties of MSC-NTF cells,
including their effects on T and B regulatory cells, and the
observed increase in IL-10 secretion, may be an important
contributor to the potential therapeutic benefits of NurOwn in ALS
and progressive MS.”
“Brainstorm is committed to fully developing
NurOwn technology while continuing to expand our understanding of
potential biological mechanisms of action that may contribute to
its therapeutic effects in neurodegenerative diseases,” said Chaim
Lebovits, Brainstorm CEO, “We look forward to advance our
technology platform across several neurodegenerative disease
indications and bring much-needed solutions to patients.”
Brainstorm AAN 2020 abstract:MSC-NTF Cell Immunomodulation:
Effects on T and B Regulatory Cells Revital Aricha, Natalie
Abramov, Jonathan Semo, Haggai Kaspi, Chaim
Lebovits, Ralph Kern.
About NurOwn® NurOwn® (autologous MSC-NTF cells)
represent a promising investigational 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. NurOwn® is
currently being evaluated in a Phase 3 ALS randomized
placebo-controlled trial and in a Phase 2 open-label multicenter
trial in Progressive MS.
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® Cellular Therapeutic
Technology Platform used to produce autologous MSC-NTF cells
through an exclusive, worldwide licensing agreement as well as
through its own patents, patent applications and proprietary
know-how. 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 the 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 BLA filing for
U.S. FDA approval of autologous MSC-NTF cells in ALS.
BrainStorm received U.S. FDA clearance to initiate a
Phase 2 open-label multi-center trial of repeat intrathecal dosing
of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718)
in December 2018 and has been enrolling clinical trial
participants since March 2019. For more information, visit the
company's website.
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.
CONTACTSInvestor Relations:
Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell
Therapeutics Inc. Phone: + 1.862.397.1860
pshah@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR PR Phone:
+1.646.677.1839 sean.leous@icrinc.com
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