BrainStorm Cell Therapeutic on the road to Clinical Studies in Parkinson's Disease
Company Reports Preliminary Results from Safety Supporting Study in Primates
NEW YORK & PETACH TIKVAH, Israel â€“ August 14, 2007 â€“ BrainStorm Cell Therapeutics, a leading developer of adult stem cell technologies and therapeutics, is pleased to announce preliminary results from its first safety supporting experiment. On February 8, 2007 in laboratories at the University of Navarra, Pamplona, Spain, Prof. Jose Obeso transplanted the subject, a healthy monkey, with BrainStorm`s human bone marrow derived mesenchymal stem cells.Â The stem cells had been induced to differentiate into neurotrophic factor-producing cells, according to the protocol developed at the Company`s laboratories in Israel.Â Â
The monkey was treated daily with cyclosporine to prevent rejection of the human originating cells by its immune system, and was monitored for a variety of parameters for a period of three months. Throughout this phase, the monkey appeared well and in good health, with a usual appetite, and with no apparent change in physical and behavioral parameters. Blood tests, an MRI of the monkeyâ€™s brain and an autopsy examination of the internal organs were also found to be normal.Â
Additionally, brain tissues from the monkey were examined by Prof. Jeffrey Kordower (Rush University, Chicago, USA). A few human originating cells were detected in sections of the monkeyâ€™s brain by staining the sections with an antibody, which can distinguish between the monkeyâ€™s own brain cells and the human transplanted cells. The human transplanted cells were surrounded by macrophages, which may indicate a reaction of the monkeyâ€™s immune system to the transplanted human cells and their initial rejection. BrainStorm`s actual approach would involve autologous transplantation (i.e., the use of the patientâ€™s own bone marrow-derived stem cells). With this strategy, no rejection is expected and there will be no need to suppress the immune system by medications that often cause severe side effects.
"We are extremely pleased with the faster pace and direction in which the Company is now moving," commented Chaim Lebovits, President of BrainStorm.Â Â "The recent financing the Company has received will, with G-d's help, allow BrainStorm to move forward with the preparations necessary toward carrying out Phase I/II clinical trials in patients with Parkinson's disease, and providing the funding and support needed to conductÂ additional safety pharmacology studies, such as toxicology."
Two additional normal monkeys recently underwent transplantation in Pamplona with BrainStormâ€™s human stem cells. The monkeys will also be monitored for a period of three months for collection of additional data; so far, the monkeys are in good health.
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.Â