NEW YORK, May 27, 2020 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult
stem cell therapies for neurodegenerative diseases, announced today
that Stacy R. Lindborg, Ph.D. has been appointed Executive
Vice President Head of Global Clinical Research effective June
1, 2020. Dr. Lindborg is an experienced healthcare
professional and globally recognized medical statistician with over
24 years of multinational experience in R&D, regulatory,
strategy development, analytics and big data.
Prior to her appointment at BrainStorm, Dr. Lindborg spent 8
years at Biogen Inc. the global biotech that discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases. She held
several senior leadership positions, most recently Vice President,
Analytics and Data Science, where she built a world class Analytics
and Data Sciences team, responsible for global data as well as
statistical and epidemiological support for R&D and marketed
products. She served on R&D governance during a time of
significant growth for Biogen, and was active in guiding the firm's
long-term vision for growth through analytics and by stimulating
innovative development platforms to increase productivity. As the
portfolio grew to tackle a diverse set of neurological diseases,
Dr. Lindborg motivated novel analytic and development approaches,
shaving time off novel drug approvals to globally address chronic
diseases. Her accomplishments at Biogen included a leadership
role in seeking, receiving and maintaining global marketing
approvals for Zinbryta®, Plegridy® and
Spinraza®, all of which included novel data analytical
elements. The Phase 3 Spinraza program was recognized with
the prestigious 2017 Prix Galien Award Winner for Best
Biotechnology Product (the biomedical industry's highest
accolade). She also played a key role in the Phase 3
development program for Aducanumab in Alzheimer's
Disease.
"The investigational NurOwn® technology platform
currently in Phase 3 and Phase 2 for ALS and progressive MS,
respectively, have life changing potential. This has been the most
significant factor in my decision to join Brainstorm," said Dr.
Stacy R Lindborg. "I have been impressed by the leadership, depth
of talent and aspiration of goals at BrainStorm. I look forward to
seeing NurOwn and the Company's pipeline advance across all stages
of clinical development."
Chaim Lebovits, Chief Executive
Officer of BrainStorm, commented, "Stacy's experience in launching
and commercializing highly visible top selling neuroscience- based
pharmaceutical products and her expertise in product launches from
NDA to post-approval marketing studies make her exceptionally well
qualified to join the BrainStorm leadership team at this pivotal
time in the Company's history. She has played leadership roles in
clinical trial design and regulatory interactions for development
stage and marketed products in neuroscience, immunology and orphan
diseases. Her experience includes global organization design
and development at two of the world's leading neurology companies,
including substantial corporate builds. Without question Dr.
Lindborg, will significantly enhance our global commercialization
and regulatory strategy, as we work to bring better treatment
options to patients afflicted with neurodegenerative diseases. We
look forward to the strategic contributions and insights she will
being to BrainStorm."
Prior to her roles in Biogen, from 1996 to 2012, Dr. Lindborg
held positions of increasing responsibility at Eli Lilly and
Company. As Head of R&D strategy, she was responsible for
characterizing the productivity of the portfolio and driving key
R&D strategy projects including the annual R&D Long-Range
Plan. In this role, she created seminal insights into R&D
productivity by connecting individual drug program-based
development decisions to portfolio risk practices, driving
fundamental R&D decisions to increase number of drug launches.
Additionally, she was Leader of Zyprexa Product Management in which
she was responsible for R&D, Commercial and Manufacturing
plans. She was accountable for driving market share through product
differentiation, global registration and launching of an injectable
form of Zyprexa, working through regulatory manufacturing
inspections and 483 citations. Zyprexa had peak sales of
$4.7 billion.
Dr. Lindborg holds a Ph.D. in statistics from Baylor University. She has been active in
professional organizations across her career, holding numerous
positions within the American Statistical Association and
International Biometric Society, having been elected Fellow of the
association in 2008. She serves on the Scientific Advisory Board of
biotechnology and technology companies and on the board of
directors of the Massachusetts Down Syndrome Congress. She was a
Board Member to the Strategic Initiative: Women in Statistics. Dr.
Lindborg was also profiled in the book "STEM Gems" (2017) as the
only women from the pharmaceutical industry highlighted as a leader
in science, technology, engineering and mathematics.
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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SOURCE Brainstorm Cell Therapeutics Inc