Message #6 From:
Stock News Bot Date: July 11, 2006 05:30:00 AM
BCLI News BrainStorm Advances Its International Patent Application (PCT) for Stem Cell Procedure with Potential for Treating Parkinson's and Other Neurodegenerative Diseases
NEW YORK & TEL AVIV, Israel--(BUSINESS WIRE)--July 11, 2006--BrainStorm Cell Therapeutics (OTCBB:BCLI) announced today that it has advanced its patent application from a provisional to an international patent application for a new procedure to derive "neuronal-supporting cells" from adult bone marrow with the US Patent and Trademark Office. The patent protects a procedure for inducing bone marrow stem cells to differentiate into astrocytes, which are brain cells that naturally support neurons in the brain. The induced cells display astrocyte-like morphology, express typical astrocyte proteins and most importantly, have the capacity to synthesize and secret neurotrophic factors, including glial-derived neurotrophic factor (GDNF). GDNF is the most potent neurotrophic factor known for dopaminergic neurons, the cells that degenerate in patients with Parkinson's disease.
Transplanting these neuronal-supporting astrocyte cells--acting on their own or in combination with dopamine-producing cells--holds great promise for the replacement of and/or preservation of neurons in Parkinson's and other neurodegenerative diseases.
The invention involves inducing adult bone marrow stem cells to differentiate into neuronal supporting cells using the proprietary stem cell technology developed at Tel Aviv University. The latest patent application was filed by the technology transfer company of Tel Aviv University, Ramot, on the basis of research funded by Brainstorm. Worldwide rights to the development and commercialization of the new technology are exclusively licensed to BrainStorm.
"Developing the capability to induce adult stem cells to differentiate into cells that secrete a battery of neurotrophic factors is a major step forward because of the important role that these factors are believed to have in brain cell survival and growth," said Yoram Drucker, Principal Executive Officer of BrainStorm. "Neurotrophic factors have the capacity to protect neurons and induce neural sprouting, and hold great promise for the treatment of many neurodegenerative diseases, including Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and even Alzheimer's disease," he added.
BrainStorm has previously announced observing a significant beneficial effect of transplanting GDNF-producing cells--derived from human bone marrow stem cells utilizing the propriety technology--into animal models of Parkinson's disease. The scientific team transplanted the GDNF-producing cells into rats with Parkinson's disease, generated by specifically damaging their dopaminergic cells. Within just two weeks of cell transplantation, the team observed significant improvement in the rats' characteristic disease behavior, including more than 50% reduction in rotational movements and enhancement in their paw reaching capacity. The beneficial effect was maintained for over four months.
Other routes of delivery of GDNF to the disease site have proven difficult to achieve. GDNF is a protein and, as such, has limited stability and ability to penetrate the brain. Attempts made to deliver the protein directly into the brain have met with limited success. An alternative approach, to deliver GDNF by genetic therapy, suffers the limitations and risks of using viral vectors. Other cell therapeutic approaches using either genetically engineered or differentiated embryonic and neural stem cells are limited by issues of graft rejection and potential tumorogenic risk.
"BrainStorm's approach of using patient-derived differentiated stem cells holds the promise to overcome the above pitfalls. Recognized as the patient's own cells, there should be no graft rejection. Moreover, unlike embryonic cells, the bone marrow derived-cells are not known to be tumorogenic. Thus, the newly transplanted cells are expected to survive and integrate, releasing the therapeutic GDNF in a physiological manner," said Dr. Daniel Offen, Chief Scientist.
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 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, enabling 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 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 can be harvested from fetal or embryonic tissue or from adult tissue reservoirs such as bone marrow. Use of embryonic stem cells is at the center of significant ethical and moral debate. In contrast, use of adult stem cells does not provoke 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, scientists are exploring both embryonic stem cells (ESC) and adult stem cells (ASC) as the potential basis for multiple cell therapy products.
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, 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; limited cash resources and its need to raise additional capital to execute on its business plan and continue operations; transition issues related to the departure of its CEO; 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 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.
