BrainStorm’s NurOwn® Phase 3 ALS Clinical Trial Now Fully Enrolled
October 11 2019 - 12:00AM
BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today that it has fully enrolled the
200-patient Phase 3 clinical trial evaluating repeat intrathecal
administration of NurOwn® Cellular Therapeutic (autologous MSC-NTF
cells) in ALS (Amyotrophic Lateral Sclerosis). BrainStorm’s Phase 3
clinical trial is being conducted at the University of California,
Irvine; Cedars-Sinai Medical Center; California Pacific Medical
Center; Massachusetts General Hospital; University of Massachusetts
Medical School; and the Mayo Clinic.
“The BrainStorm team is very excited to reach
this important milestone in the development and potential
commercialization of NurOwn in ALS. We have been fully dedicated to
this journey since we began clinical trial enrollment in October
2017. To date, a significant percentage of the 200 enrolled
patients have received three treatments and we expect that all
trial participants will complete planned study visits and
assessments by October 2020.” commented Chaim Lebovits, President
and CEO of BrainStorm.
“Having reached this turning point in our
Company’s history, I would like to publicly acknowledge the
professionalism and commitment of the clinical investigators, but,
most of all, I want to express my sincere gratitude to the many
patients and their families, who by participating in this trial
have confirmed their belief in the potential of NurOwn. The entire
BrainStorm team is grateful for your contribution in advancing the
development of NurOwn and our understanding of ALS.”
Maria Millan, MD, President and CEO of the
California Institute for Regenerative Medicine (CIRM) said, “CIRM’s
mission is to accelerate stem cell treatments to patients with
unmet medical needs. ALS is a debilitating and fatal
neurodegenerative condition for which there is no effective
treatment. Based on BrainStorm Cell Therapeutics’ scientific and
early phase clinical trial data, CIRM awarded them $15.9 million to
advance their investigational therapy NurOwn into a Phase 3 trial.
Our support helped bring this program to three leading California
medical centers. We congratulate Brainstorm Cell Therapeutics in
completing enrollment, an important milestone toward developing a
much-needed treatment for ALS.”
Ralph Kern, MD, MHSc, Chief Operating Officer
and Chief Medical Officer of BrainStorm stated, “We are very
pleased to have fully enrolled our Phase 3 randomized
placebo-controlled clinical trial in ALS and look forward to
reporting top-line results before the end of next year. This
clinical milestone is a key inflection point in the development of
NurOwn. We are deeply thankful to many who have made an important
contribution to this effort and look forward to quickly completing
all clinical and biomarker analyses in support of the filing of a
biological license application with the goal of bringing an
innovative and much needed treatment option to ALS patients.”
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. 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
Statements
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 LeousWestwicke/ICR
PR Phone: +1.646.677.1839sean.leous@icrinc.com
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