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BrainStorm on the Verge of a Breakthrough Towards Developing a Cure for Lou Gehrig's Disease
Business Wire, Oct 8, 2007
Company Announces Exciting Positive Results in Pilot Studies
NEW YORK & PETACH TIKVAH, Israel -- BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that the Company is initiating a series of efficacy and safety studies toward a cure for Amyelotrophic Lateral Sclerosis (ALS).
ALS or Lou Gehrig's disease, named after the famous baseball player who succumbed to the illness, is a rare and incurable neurodegenerative disease characterized by rapid loss of motor neurons leading to impaired motor-function and progressive paralysis. As the disease progresses, the patient loses control of the muscles controlling speech, swallowing and finally breathing, which inevitably becomes fatal within 3-5 years from onset for the vast majority of patients. ALS afflicts an average of two out of 100,000 individuals and six out 100,000 persons suffer from the disease. The cause of the disease is yet unknown.
The scientific team at the Tel Aviv University Neuroscience laboratory led by Prof. Eldad Melamed and Dr. Daniel Offen, has transplanted BrainStorm's human neurotrophic factor (NTFs) producing cells into transgenic mutant SOD mice (mice with mutated human genes and the most common animal model of the human disease). Preliminary results demonstrated remarkable effect on the deteriorated motor function as measured by performance on running rotational rods.
"During our study, BrainStorm's technology was used to differentiate adult stem cells, which will be able to be extracted from ALS patients, into cells producing the neurotrophic factors," explained Dr. Offen. "Significant improvement in motor function was achieved once we implanted the cells into a mouse model of ALS. These positive results bring us closer to clinical trials as we continue to design additional studies to support our data."
The transplanted cells were isolated from human bone marrow, expanded in vitro and induced to differentiate into cells that produce neuroprotective factors including GDNF and BDNF, which have been shown to protect neurons in certain neurodegenerative diseases. The company is moving forward with additional studies and further results will be analyzed and reported accordingly.
"We are extremely pleased to spearhead adult stem cell efforts toward a cure for Lou Gehrig's disease," commented Chaim Lebovits, President of BrainStorm. "The devastation of ALS is often displaced amongst the other more familiar neurodegenerative diseases. BrainStorm recognizes the severity of this disease, and, thank G-d, is pleased so far with our progress toward alleviating its effects."
BrainStorm's cell therapeutic approach is based on the transplantation of the patient's own bone marrow-derived mesenchymal stem cells, which are stimulated to differentiate ex-vivo into NTF producing cells. These cells, when administered back into the patient, are believed to provide neuroprotection of motor-neurons. This results in improved motor function as well as improvement of the clinical symptoms. BrainStorm's large-scale efficacy studies will provide additional data to support the initial pilot study.
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 NurOwn(TM) patent pending technology is based on discoveries made by the scientific team led by prominent neurologist Professor Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, 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 Parkinson's disease, although its technology has promise for treating several others diseases including MS, ALS, Huntington's disease and stroke.
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 BrainStorm's ability to complete its equity financing transactions previously disclosed. The potential risks and uncertainties include, among others, risks associated with BrainStorm Cell Therapeutics Inc.'s limited operating history, history of losses and expectation to incur losses for the foreseeable future; dependence on its license to Ramot's technology; ability, together with its licensor, to adequately protect the NurOwn[TM] technology; dependence on key executives and on its scientific consultants; ability to identify, negotiate and successfully implement strategic partnering 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.'s market; the limited public trading market for BrainStorm Cell Therapeutics Inc.'s stock which may never develop into an active market; and other factors detailed in BrainStorm Cell Therapeutics Inc.'s annual report on Form 10-KSB, quarterly reports on Form 10-QSB, current reports on Form 8-K and other filings with the Securities and Exchange Commission available at http://www.sec.gov/ or by request to the Company. The Company does not undertake any obligation to update forward-looking statements made by us.
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