Brainstorm Cell Therapeutics Inc : BrainStorm Announces Clinical Data Supporting Safety and Efficacy of NurOwn? Based on Initial Patient Results
01/17/2012| 09:20am US/Eastern
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BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), an innovative developer
of adult stem cell technologies and Central Nervous System (CNS)
therapeutics, today announced that the data from the initial patients in
its ALS Phase I/II human clinical trial treated with its NurOwn?
technology did not present any significant side effects and that the
NurOwn? treatment has so far proven to be safe. Prof. Dimitrios
Karussis, who is leading the clinical trial at Hadassah Medical Center,
stated, "There have been no significant side effects in the initial
patients we have treated with BrainStorm's NurOwn? technology. In
addition, even though we are conducting a safety trial, the early
clinical follow up of the patients treated with the stem cells shows
indications of beneficial clinical effects, such as an improvement in
breathing and swallowing ability as well as in muscular power. I am very
excited about the safety results, as well as these indications of
efficacy, we are seeing. This may represent the biggest hope in this
field of degenerative diseases, like ALS."
After reviewing the safety data from the first four patients, the
Hadassah Medical Center ethical committee granted approval for the trial
to advance to transplanting the next patients.
"We are happy to report that the first patients treated with our NurOwn?
technology did not present any significant side effects. This supports
and strengthens our belief and trust in our technology. Based on the
interim safety report, the hospital ethical and safety committee granted
the company approval to proceed with treating the next patients. We are
pleased with the progress we are making and look forward to continuing
to demonstrate the safety of NurOwn? in the future," said Chaim
Lebovits, BrainStorm's President.
The ALS Phase I/II human clinical trial is being performed at Hadassah
Medical Center in Israel in collaboration with BrainStorm and is
utilizing BrainStorm's NurOwn? technology for growing and modifying
autologous adult human stem cells to treat ALS, often referred to as Lou
Gehrig's Disease. The study is headed by Prof. Karussis, M.D., Ph.D.,
who is the head of Hadassah's Multiple Sclerosis Center and a member of
the International Steering Committees for Bone Marrow and Mesenchymal
Stem Cells Transplantation in Multiple Sclerosis (MS), and a scientific
team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of
the study is designed to establish the safety of NurOwn? and will later
be expanded to assess efficacy.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's
Disease, is a progressive neurodegenerative disease that affects nerve
cells in the brain and the spinal cord. According to the ALS
Association, approximately 5,600 people in the U.S. are diagnosed with
ALS each year and it is estimated that as many as 30,000 Americans may
have the disease at any given time.
About NurOwn?
BrainStorm's core technology, NurOwn?, is based on the scientific
achievements of Professor Eldad Melamed, former Head of Neurology, Rabin
Medical Center, and Tel-Aviv University, and a member of the Scientific
Committee of the Michael J. Fox Foundation for Parkinson's Research, and
Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein
Medical Research Center (FMRC) at the Tel-Aviv University.
The NurOwn? technology processes autologous adult human mesenchymal stem
cells that are present in bone marrow and are capable of self-renewal as
well as differentiation into many other cell types. Adult human bone
marrow cells are induced to differentiate into astrocyte-like cells
capable of releasing neurotrophic factors, including glial-derived
neurotrophic factor (GDNF) by means of a specific
differentiation-inducing culture medium. The ability to induce
differentiation into astrocyte-like cells along with intramuscular or
intrathecal (or other) delivery makes NurOwn? technology highly
attractive for treating ALS and Parkinson's disease as well as MS and
spinal cord injury.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotech company developing adult
stem cell therapeutic products, derived from autologous (self) bone
marrow cells, for the treatment of neurodegenerative diseases. The
company, through its wholly owned subsidiary Brainstorm Cell
Therapeutics Ltd., holds rights to develop and commercialize the
technology through an exclusive, worldwide licensing agreement with
Ramot at Tel Aviv University Ltd., the technology transfer company of
Tel-Aviv University. The technology is currently in a Phase I/II
clinical trials for ALS in Israel.
Safe Harbor Statement
Statements in this announcement other than historical data and
information 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, including, inter alia, regarding safety and
efficacy in its human clinical trials and thereafter; the Company's
ability to progress any product candidates in pre-clinical or clinical
trials; the scope, rate and progress of its pre-clinical trials and
other research and development activities; the scope, rate and progress
of clinical trials we commence; clinical trial results; safety and
efficacy of the product even if the data from pre-clinical or clinical
trials is positive; uncertainties relating to clinical trials; risks
relating to the commercialization, if any, of our proposed product
candidates; dependence on the efforts of third parties; failure by us to
secure and maintain relationships with collaborators; dependence on
intellectual property; competition for clinical resources and patient
enrollment from drug candidates in development by other companies with
greater resources and visibility, and risks that we may lack the
financial resources and access to capital to fund our operations The
potential risks and uncertainties include risks associated with
BrainStorm's limited operating history, history of losses; minimal
working capital, dependence on its license to Ramot's technology;
ability to adequately protect its technology; dependence on key
executives and on its scientific consultants; ability to obtain required
regulatory approvals; 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.
The Company does not undertake any obligation to update forward-looking
statements made by us.
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI)
Adrian Harel,
Ph.D., Acting CEO
+972-3-9236384
aharel@brainstorm-cell.com
www.brainstorm-cell.com
© Business Wire 2012
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