New York, USA & Petach Tikvah, Israel – B3C newswire – BrainStorm Cell Therapeutics Inc.,
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
BrainStorms 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, BrainStorms
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 BrainStorms 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™
BrainStorms 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 Parkinsons 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.
Posted by Sean Fenske, Editor-in-Chief, MDT