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| 8-K - BRAINSTORM CELL THERAPEUTICS INC. | v198753_8k.htm |
BrainStorm
Receives Approval to Begin Clinical Trial of Adult Stem Cell Therapy in Patients
with ALS
Building
on Nearly Five Years of Research, BrainStorm is the First Company to Receive
Clearance from the Israeli Ministry of Health for a Differentiated Stem
Cell-Based Therapy in Israel
New York
and Petach Tikvah, Israel – October 11, 2010 - BrainStorm Cell Therapeutics Inc.
(OTCBB: BCLI), a leading developer
of adult stem cell technologies and therapeutics, today announced that the Israeli Ministry of Health (MOH) has granted clearance for a Phase I/II clinical
trial using the company’s autologous NurOwn™ stem cell therapy in patients with
amyotrophic lateral
sclerosis (ALS), often
referred to as Lou Gehrig's Disease. BrainStorm is the first company to receive clearance from the MOH for
a differentiated stem cell-based therapy in Israel.
“The Israeli Ministry of Health’s clearance of our NurOwn™ clinical trial is one of BrainStorm’s most significant accomplishments to
date,” said Chaim Lebovits, President of
BrainStorm. “We believe that our specific differentiated stem cells
derived from a patient’s own bone marrow could represent a new treatment paradigm for patients with ALS
and other neurological disorders.”
The Phase I/II clinical trial will be
conducted in cooperation with the world-renowned Hadassah Medical Center and will be conducted by a joint team
headed by the principal investigator Dimitrios Karussis, M.D., Ph.D., of the Hadassah Medical Center, 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.
The trial is expected to begin following validation of sterility tests requested
by the MOH and screening of patients for the trial. Additional information regarding the
process of selecting patients for the Phase I/II clinical trial will be
communicated at a later date.
“I am extremely pleased to learn about
this new development," said Dr. Jacob Frenkel, Chairman
of JPMorgan Chase International and a member of the JPMorgan Chase (NYSE:
JPM) Executive Committee and its
International Council and a member of the Advisory Board of
BrainStorm. "I wish to express my appreciation to
the Israeli Ministry of Health for approving BrainStorm's application and
allowing the researchers in the company to try to bring hope for the patients
who are waiting anxiously for a successful treatment.”
“We are very excited by
this new approach to develop neuronal supporting cells; the hope is that these
cells will be neuroprotective and clinically beneficial in several neurological
diseases, such as ALS and Parkinson’s Disease,” said Robert H. Brown Jr., M.D.
Ph.D., Professor and Chair of Neurology at the University of Massachusetts
Medical School. “Successful slowing of these diseases using these
neural-supporting mesenchymal cells would have a profound impact on the
field. If safe and effective, this new therapy could become a
treatment option for thousands of patients.”
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. The financial cost to
families of patients is exceedingly high, and it is estimated that in the
advanced stage, care can cost an average of $200,000 per year, which represents
more than a $6 billion cost to the healthcare system.
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 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. The research team is among the first to have successfully
achieved the in vitro differentiation of adult bone marrow
cells (animal and human) into astrocyte-like cells capable of releasing
neurotrophic factors, including glial-derived neurotrophic factor (GDNF). 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.
BrainStorm’s stem cell therapy
contains human mesenchymal stromal cells induced
to differentiate into astrocyte-like cells secreting neurotrophic factors by
means of a specific differentiation-inducing culture medium.
About BrainStorm Cell Therapeutics,
Inc.
BrainStorm Cell Therapeutics Inc. is an
emerging company developing adult stem cell therapeutic products, derived from
autologous (self) bone marrow cells, for the treatment of neurodegenerative
diseases. The Company 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. 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 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. 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 the 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.
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Company
Contact:
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Investors/Media
Contact:
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Rami Efrati,
CEO
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Michael Becker, Senior
Partner
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BrainStorm Cell
Therapeutics
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MD Becker Partners
LLC
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Phone:
+972-3-9236384
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Phone:
+1-267-756-7094
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Email: efrati@brainstorm-cell.com
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Email: brainstorm@mdbpartners.com
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