FROM: BusinessWire
July 18, 2005 07:00 AM US Eastern Timezone
BrainStorm Cell Therapeutics Announces Adult Stem Cell Breakthrough
for Neurodegenerative Diseases; Differentiation into GDNF-Producing
Astrocytes
NEW YORK & TEL AVIV, Israel--(BUSINESS WIRE)--July 18, 2005--
BrainStorm Cell Therapeutics (OTCBB:BCLI), today announced a
breakthrough in the development of adult stem cell therapeutics for
neurodegenerative diseases. The company's scientific collaborators at
Tel Aviv University, have successfully used adult stem cells to
produce glial derived neurotrophic factor (GDNF). GDNF producing
cells hold great promise for treatment of Parkinson's and other
neurodegenerative diseases.In the current study, the research team at Tel Aviv University usedproprietary technology, to differentiate human bone-marrow-derivedmesenchymal-stem cells into neural supporting cells that produceGDNF. Worldwide rights to these research results are exclusivelylicensed to BrainStorm.GDNF has been shown to protect dopaminergic brain cells, neurons thatproduce dopamine that becomes depleted in Parkinson's patients. GDNF has also been shown to have a beneficial role in protecting neurons in animal models of Amyotrophic Lateral Sclerosis (ALS) and SpinalCord Injury (SCI).
Most of the current treatment of neurodegenerative diseases provide
limited benefit to patients. Drugs for Parkinson's disease, which
focus on dopamine supplementation, often cause prohibitive side
effects. To overcome these problems, researchers around the world are
intensively exploring novel cell- and gene-based therapies for
replacement and augmentation of the lost neurons. Prominent among
these novel therapies are attempts to deliver GDNF to the site of
neuronal regeneration. In the current BrainStorm-sponsored study at Tel Aviv University, biochemical and immunological methodology showed that human bone marrow mesenchymal stem cells may be uniquely differentiated into cells that resemble astrocytes, express astrocytic markers and
produce significant levels of GDNF.The same scientific team at Tel Aviv University, led by ProfessorEldad Melamed and Dr. Daniel Offen, have previously developed patent-pending technology to differentiate human bone marrow into dopamineproducing neuron-like cells, which showed functional benefit in animal models of Parkinson's disease. This technology is alsoexclusively licensed to BrainStorm.
"Neurologists have long thought that GDNF can be used to preserve and
maintain the integrity of dopaminergic neurons in Parkinson's
disease. However, delivery to the appropriate location is a major
challenge. Direct delivery of the protein has failed and there are
current ongoing attempts at gene therapy. We believe that our
approach, based on neural transplantation of stem cell derived GDNF
producing cells, without any genetic manipulation, is preferable,"
said Prof. Eldad Melamed, Chairman of the Scientific Advisory Board.
In addition, "The use of a patient's own bone marrow stem cells to
generate neural cells for replacement and support of a patient's
damaged dopaminergic cells is a strategy that will avoid problems of
immunological rejection," said Dr. Daniel Offen, Chief Scientist.
"This is a remarkable achievement which combined with our previous
success in producing dopaminergic cells, gives us a two-pronged,
synergistic approach to develop long term alternatives for the
treatment of Parkinson's disease and other debilitating disorders,
such as ALS or SPI," said Yaffa Beck, President and CEO. " We look
forward to demonstrating benefit of the GDNF producing cells in
animal models and are intent on developing both our dopaminergic and
GDNF differentiation processes to the clinic," she added. About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is an emerging company developing neural-like stem cell therapeutic products, NurOwn(TM), based on autologous bone marrow derived stromal cells, for treatment of neurodegenerative diseases. NurOwn(TM) patent pending technology is based on discoveries made by the team of prominent neurologist, Prof. Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, at the Felsenstein Medical Research Center of Tel-Aviv University, enabling the differentiation of bone marrow derived stem cells into functional neurons, as demonstrated in animal models. 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. The company's initial focus is on developing treatments for Parkinson's Disease.
About Stem Cell Therapy
Stem cells are non-specialized cells with a remarkable potential for
both self-renewal and differentiation into cell types with a
specialized function, such as muscle, blood or brain cells. Stem
cells may be sourced from fetal or embryonic tissue or from adult
tissue reservoirs such as bone marrow. Use of embryonic stem cells,
has become the center of significant ethical and moral debate. In
contrast, use of adult stem cells does not face the same moral or
legal controversy. Stem cell therapy aims to "cure" disease by
replacing the 'diseased' cells with 'healthy' cells derived from stem
cells. This approach has the potential to revolutionize medicine and,
if successful, the implied commercial opportunities are great.
Currently, both embryonic stem cells (ESC) and adult stem cells (ASC)
are being explored as the potential basis for multiple cell therapy
products.
About Parkinson's Disease Parkinson's Disease (PD), which was first described by James Parkinson in 1817 as "the shaking palsy", is a chronic, progressiveneurodegenerative disorder, affecting the brain cells responsible for production of dopamine. The symptoms include tremors, rigidity, slowness of movement and impaired balance. Over four million people in the developed world, including as many as 1.5 million Americans, mainly over the age of 65, are diagnosed with PD. That figure is predicted to rise by 10% by 2010. Pharmaceutical treatments of PD with an estimated combined annual market value of $4 billion, are insufficient to meet patient needs. The search for more effectivetreatments continues. Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risksand uncertainties that could cause BrainStorm Cell Therapeutics Inc.actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and
uncertainties include, among others, risks associated with BrainStorm
Cell Therapeutics Inc. limited operating history, history of losses
and expectation to incur losses for the foreseeable future; need to
raise additional capital to execute on its business plan; dependence
on its license to Ramot's technology and ability to meet its funding
and payment obligations included in such license agreement; ability,
together with its licensor, to adequately protect the NurOwn(TM)
technology; dependence on key executives who have recently joined the
company and on its scientific consultants; ability to identify,
negotiate and successfully implement strategic par!
tnering relationships; ability to complete clinical trials
successfully and to obtain required regulatory approvals; competition
with companies, some of which have greater resources and experience
in developing and obtaining regulatory approval for treatments in
BrainStorm Cell Therapeutics Inc. market; the limited public trading
market for BrainStorm Cell Therapeutics Inc. stock which may never
develop into an active market; and other factors detailed in
BrainStorm Cell Therapeutics Inc. annual report on From 10-KSB,
quarterly reports on Form 10-QSB, current reports on From 8-K and
other filings with the Securities and Exchange Commission available
at
http://www.sec.gov/ or by request to the Company.