Message #11 From:
NewsBot Date: September 12, 2006 04:30:00 AM
BCLI News BrainStorm Cell Therapeutics Enters Letter of Intent to Begin Preclinical Primate Studies of Stem Cell-Based Therapy for Parkinson's Disease; Testing to Begin by Year-End, With Clinical Human Trials to Follow As Soon As Possible
NEW YORK--(BUSINESS WIRE)--Sept. 12, 2006--BrainStorm Cell Therapeutics (OTCBB:BCLI), a leader in Adult Stem Cell Research, announced today that it has entered into a Letter Of Intent (LOI) with the Center for Applied Medical Research (CIMA) of the University of Navarra to conduct safety trials in primates of the Company's Parkinson's disease stem cell therapy. The team at the Movement Disorders Unit in Parkinson's Disease at the University has over 20 years experience in researching and applying new therapies to treat Parkinson's disease, and anticipates being among the first to use BrainStorm's technology to treat patients in its own University Hospital. The trials will be conducted in Pamplona, Spain, with the intention to move into human clinical trials as soon as is practically possible.
Commenting on the announcement, Yoram Drucker, BrainStorm Cell Therapeutic's Chief Operating Officer stated; "We are pleased to begin this next phase of our testing. BrainStorm has already shown efficacy for this adult stem cell therapy in both mice and rats, and we anticipate that successful results of our primate safety studies will quickly lead to clinical trials in humans. Mr. Drucker went on to say, "There are an estimated 4 million people in the Western world suffering from Parkinson's disease and we are eager to validate the therapy that we believe will provide considerable relief of their symptoms."
The LOI calls for the scientific teams of BrainStorm and CIMA to create a detailed protocol for the trials, which will then be managed by Professor Jose Obeso, Senior Scientist at the Movement Disorders Laboratory at CIMA and Chief of the Movement Disorders Unit in Parkinson's Disease at the University Hospital (University of Navarra), and Professor Eldad Melamed, Chief of Neurology at the Rabin Medical Center, Tel Aviv University and Chief Medical Officer of BrainStorm. All costs of the project will be shared evenly between the two companies.
All intellectual property rights resulting from the trials will belong exclusively to BrainStorm. CIMA, or its designee, shall receive royalty payments from the Company based on net sales from any resulting Parkinson's disease treatments. The royalty agreement will include sales in Portugal, Spain, France, and the Netherlands countries.
Professor Obeso of CIMA stated, "This is a very exciting project for us. BrainStorm's progress in adult stem cell research is renown within the scientific community and we look forward to working with them to substantiate their work in the treatment of Parkinson's disease."
The Company's anticipates the primate studies will begin by the end of this year, with human clinical trials to follow as soon as possible.
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.
About Center for Applied Medical Research (CIMA) of the University of Navarra
The Center for Applied Medical Research (CIMA) of the University of Navarra is run by the Foundation for Applied Medical Research, which was established with the encouragement of the University of Navarra Schools of Medicine, Science, Pharmacy and the University Hospital. The mission is to promote basic, translational and clinical research in the fields of health and biomedicine. CIMA is involved in different biomedical projects in the following divisions: Gene Therapy and Hepatology, Cardiovascular Sciences, Neurosciences (Parkinson and Alzheimer) and Oncology.
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.
