HACKENSACK, N.J. and PETACH
TIKVAH, Israel, Dec. 29, 2017 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem
cell therapeutics for neurodegenerative diseases, today issued a
Letter to Shareholders from its President and CEO, Chaim Lebovits
Dear Valued Shareholders,
This past year was an extraordinary success for BrainStorm Cell
Therapeutics. A key accomplishment was the enrollment of the first
US patients in the Phase 3 clinical trial of NurOwn® for the
treatment of amyotrophic lateral sclerosis (ALS). In addition to
our clinical success, we have further developed our manufacturing
capabilities in many ways, including validating the
cryopreservation process. Financially, we received additional
non-dilutive grants from the California Institute for Regenerative
Medicine (CIRM) as well as the Israel Innovation Authority.
In addition, we have further strengthened our executive team with
new key appointments.
In October, we enrolled the first patients in the randomized,
double-blind, placebo-controlled multi-dose Phase 3 clinical trial
of NurOwn® for the treatment of ALS. Our Phase 3 trial builds upon
the promising efficacy demonstrated in our Phase 2 randomized US
trial, the first ALS study data to highlight the restoration of
patient function.
As the most advanced stem cell therapy in development for the
treatment of ALS, our Phase 3 trial will enroll approximately 200
patients at six leading clinical sites in the U.S. The NurOwn®
phase 3 trial patient population will focus on the patient
sub-groups which demonstrated superior outcomes in the Phase 2 ALS
clinical trial. The primary outcome measure will be the ALSFR-S
score responder analysis, a score that measures a patient's ability
to perform tasks that are affected by ALS. We expect interim safety
data in mid 2018 and top-line data in late 2019. The phase 3 trial
will also expand upon phase 2 biomarkers to further evaluate their
potential to predict ALS disease progression and NurOwn® treatment
response.
The pivotal phase 3 NurOwn® trial is being supported by a
$16 million non-dilutive grant from
the California Institute for Regenerative Medicine (CIRM). In
addition, for the tenth consecutive year, we have received
non-dilutive grants from the Israel Innovation Authority to further
support the development of NurOwn®, including a $2.1 million grant in 2017.
We met and exceeded expectations in 2017 on the manufacturing
and product development front. As an important milestone for
potential commercialization, in early 2017 our NurOwn®
cryopreservation process was validated for the Phase 3 clinical
study for treatment of ALS. Additionally, to further expand our
manufacturing capabilities, we contracted the City of Hope's Center
for Biomedicine and Genetics, California, to produce clinical supplies of
NurOwn® for our Phase 3 trial.
We continue to explore strategic partnerships to advance
NurOwn's clinical development and maximize its market potential. In
2017 we signed a Memorandum of Understanding (MOU) to explore the
possibility of making NurOwn® available to ALS patients under
provision of the MOH Hospital Exemption regulation with Tel Aviv
Sourasky Medical Center.
In addition, this year we expanded our patent portfolio by
obtaining an additional US patent for BrainStorm's NurOwn®
technology for the treatment of ALS and Parkinson's disease. This
move further protects our technology and is a result of
BrainStorm's ongoing development and clinical successes.
In parallel to our NurOwn® successes, we strengthened our
executive team and board of directors. We added three senior
members to our executive team: Ralph Z.
Kern, MD, MHSc joined Brainstorm in a dual role as Chief
Operating Officer and Chief Medical Officer, starting in March.
In August, Mary Kay Turner
joined as Vice President of Patient Advocacy and Government
Affairs. Eyal Rubin joined early November as Chief Financial
Officer, responsible for corporate finance and accounting. These
individuals were chosen for their deep neuroscience experience,
significant industry expertise and long track record of industry
achievements.
Our Board of Directors was strengthened in February with the
addition of June S. Almenoff, M.D.,
Ph.D., FACP, and Arturo O. Araya,
M.A., M.B.A. Their vast experience in drug development and
commercialization, and cell and gene therapy are valuable assets to
our company, particularly at this important time.
This year, in addition to support enrollment in the Phase 3 ALS
clinical trial, we are also looking to advance BrainStorm's
pipeline in other neurodegenerative diseases, based on strong
preclinical data in Parkinson's disease and Multiple
Sclerosis.
In closing, management is dedicated to achieving our primary
goals to deliver value for our shareholders, to develop
transformative cell therapies for ALS and other severe
neurodegenerative diseases, and to be the leader in this
field. We have accomplished much in the past year but there
is no doubt in our mind that our best days are ahead of us. Thank
you for your continued interest in and commitment to support
Brainstorm.
Please do not hesitate to contact us directly with any
additional questions; we can be reached at
info@brainstorm-cell.com
Sincerely,
Chaim Lebovits
President and CEO
BrainStorm Cell Therapeutics Inc.
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SOURCE BrainStorm Cell Therapeutics Inc.