BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn® for The European U...
May 07 2020 - 1:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today a lease agreement with the Tel Aviv
Sourasky Medical Center (“Sourasky) in Tel Aviv, Israel, to
produce NurOwn® in three state-of-the-art cleanrooms. The new
facility will significantly increase the Company’s capacity to
manufacture and ship its product into the European Union and the
local Israeli market. The cleanroom facility is part of Sourasky’s
Institute for Advanced Cellular Therapies.
"Sourasky Hospital is a leader in the
advancement and manufacturing of cell and gene therapy products and
is well-equipped to rapidly scale up and produce NurOwn," stated
Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We
look forward to continuing our work with BrainStorm to bring NurOwn
to ALS patients and help fulfill the clinical therapy demands for
the Company’s pipeline programs.”
"Sourasky Hospital, known for introducing
pioneering solutions into clinical practice and advancing patient
care, has a first rate team with the proven experience to produce
regenerative products in accordance to the highest standard of cGMP
manufacturing," said Chaim Lebovits, CEO of BrainStorm. "This
agreement will ensure that we can provide NurOwn to patients after
regulatory approval, not only in Israel but we have secured
capacity to rapidly scale up production as we advance our
investigational treatment across the European Union. We are very
pleased to be able to expand our ongoing collaboration with
Sourasky Hospital, one of the world’s most innovative and respected
medical centers."
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
Investor 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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