Healthcare Industry News:  neurodegenerative 

Regenerative Medicine Neurology

 News Release - May 11, 2010

BrainStorm Announces Significant Milestones Achieved and 2009 Review

NEW YORK & PETACH TIKVAH, Israel--(HSMN NewsFeed)--BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI ), a leading developer of adult stem cell technologies and therapeutics provided today a review of fiscal 2009 and an update of its significant milestones achieved.

“Fiscal 2009 was an important year for BrainStorm,” stated Chaim Lebovits, President of BrainStorm. “During 2009 we completed our ALS pre-clinical trials in accordance with Good Manufacturing Practice standards at the facility of Protein Production Services Limited and in 2010 we entered into a collaborative agreement with Hadassah Medical Center to conduct our ALS clinical trials at the Hadassah Ein Kerem Hospital.”

“In addition, during fiscal 2009 and the first quarter of 2010 the Company strengthened its balance sheet and secured new capital from investors,” continued Mr. Lebovits. “The money raised will allow us to fund the first phase of our clinical trials and sustain us through the end of the fiscal 2010 and into the start of fiscal 2011.”

“Fiscal 2010 will be a pivotal year for the Company as we expect to begin our ALS clinical trials in the coming months. We are now working in our laboratory at Hadassah preparing for these clinical trials. We started testing our growth mediums at the laboratory and expect to conclude our tests in the next few weeks. We anticipate the start of the ALS clinical trials shortly thereafter once we receive approval from the National Helsinki Committee of Israel’s Ministry of Health,” concluded Mr. Lebovits.

Fiscal 2009 and 2010 Year-to-Date Highlights

* On March 4, 2009, scientists from the Tel Aviv University published research in the online edition of “Stem Cells and Development” demonstrating that human-derived adult Stem Cells may be induced to differentiate in vitro into neural-like cells and, once injected into the brain, improve impaired motor behavior in an experimental model of Parkinson's disease. These findings were a major breakthrough and demonstrated the potential promise of BrainStorm’s technology, which induces human adult stem cells to become cells that release Neurotrophic Factors.

* On August 24, 2009, the Company announced that it received funds in the form of a prestigious grant from the Israeli government’s Office of the Chief Scientist as well as from a private investment. These capital infusions demonstrated a financial vote of confidence in the Company’s breakthrough stem cell technology and provided the funding to complete the ALS pre-clinical trials at Protein Production Services Ltd.

* In October 5, 2009, the Company announced that bone marrow cells taken from ALS patients were capable of differentiating into nerve-supporting cells. The company tested ALS patients' bone marrow stem cells in order to confirm that these stem cells could undergo BrainStorm’s differentiation procedure to secrete NeuroTrophic Factors (NTF) and used for treatment by back transplantation into the patients. The experiments performed at BrainStorm’s research laboratories showed that the stem cells isolated from the bone marrow of healthy donors and ALS patients were similar, as indicated by all the morphological and biochemical parameters tested. In addition, the cellular expansion potential of stem cells from the healthy donors and from the patients was comparable. Most important, cells from both, the healthy donors and the patients, secreted NeuroTrophic Factors after applying Brainstorm’s unique differentiation protocols.

* On October 19, 2009 BrainStorm was selected to present at the Israeli Presidential Conference: Facing Tomorrow 2009 – Tomorrows Industries Exhibition as one of the innovators in the stem cell industry recognizing the accomplishments of the Company.

* On November 9, 2009 announced that in a scientific paper published in the Israel Medical Association Journal scientists from Tel Aviv University showed the migratory capacity of Neurotrophic Factor Stem Cells (NTF-SC) in animal models of Parkinson’s disease and Huntington disease. The study demonstrated that in a rat model for Parkinson’s disease, the efficacy of NTF-SC was superior to that of mesenchymal stem cells in terms of behavioral, biochemical and histological indices. This study demonstrated that Brainstorm’s approach in differentiating adult mesenchymal stem cells into NTF-SC, will provide the most effective approach for the treatment of neurodegenerative diseases via the use of stem cells.

* On November 16, 2009 announced that in a scientific paper published in the Journal of Molecular Neuroscience scientists from Tel Aviv University studied the effectiveness of human bone marrow derived stem cells induced to differentiate and secrete neurotrophic factors (NTF-SC) as compared to the use of non-differentiated stem cells in a mouse model of Multiple Sclerosis (MS). This study demonstrated that the transplantation of the NTF-SC, based on our novel differentiation technology, resulted in a delay of disease onset and increased animal survival in the mouse MS model to a greater extent than transplantation of the non-differentiated stem cells. It was shown that the NTF-SC modulate the immune system and protect neuronal cells from toxic insults. The positive results in the mouse MS model demonstrated that our technology may provide an effective strategy not only for the treatment of ALS and Parkinson’s disease but also for the treatment of MS.

* In January 2010 the Company received visits from the Israeli Minister of Science and Technology, the Israeli Minister of Industry, Trade and Labor and the Israeli Chief Scientist. These visits demonstrated the importance of the work that the Company is doing.

* On February 17, 2010 the Company announced that it raised $1.5 million from three investors.

* On February 22, 2010 the Company announced that it entered into a collaborative agreement with Hadassah Medical Center to conduct its ALS clinical trials at the Hadassah Ein Kerem Hospital.

* On February 23 and 24, 2010 the Company was featured on MSNBC and Fox News.

* On April 14, 2010 the Company announced the appointment of Avi Israeli to Chairman of the Board of Directors. Professor Israeli, is a Medical Doctor specializing in Internal Medicine and in Health Care Management. He has previously served as the Director General of the Israeli Ministry of Health, as well as the Director General of The Hadassah Medical Organization. He currently heads the Department of Health Policy, Health Care Administration and Health Economics at Hebrew University and Hadassah Medical School and the School of Public 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 patent pending technology is based on discoveries made by the scientific team led by Professor Eldad Melamed, former Head of Neurology at Rabin Medical Center, and cell biologist Prof. 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 current focus is on ALS, although its technology has promise for treating several other diseases including MS, 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. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.


Source: BrainStorm Cell Therapeutics

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