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BrainStorm Initiates Clinical Trials and Holds Successful Shareholders Meeting

^{Published on 2011-06-13 07:10:57 - Market Wire}
 

NEW YORK & PETACH TIKVAH, Israel--([ BUSINESS WIRE ])--BrainStorm Cell Therapeutics (OTCBB: BCLI), a developer of adult stem cell technologies and CNS therapeutics, announced today that together with the Hadassah Medical Organization, a successful study initiation/clinical trial kickoff meeting was held on June 6, 2011 at the Hadassah Medical Center and with this meeting the trial is underway. BrainStorm is the first company to receive approval from the Israeli Ministry of Health (MOH) for a differentiated stem cell-based therapy and approval of its Phase I/II clinical trial utilizing its proprietary NurOwna" treatment for patients with Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's Disease.

BrainStorm is also proud to announce that its Annual Shareholdersa™ Meeting was held on Friday, June 10, 2011, at the Company's offices in New York City. At the meeting the shareholders approved the nomination of the existing directors Dr. Abraham Israeli, Dr. Irit Arbel, Mordechai Friedman, Alon Pinkas, Dr. Robert Shorr and Malcolm Taub to serve as directors for another year. In addition, the shareholders approved the appointment of Brightman Almagor Zohar and Co., a member of Deloitte Touche Tohmatsu, as the Companya™s independent registered public accounting firm, for an additional year.

About the Trial

The Phase I/II clinical trial will be conducted by a joint team headed by the principal investigator Prof. Dimitrios Karussis, M.D., Ph.D., Director of the Center for Multiple Sclerosis at the Department of Neurology of the Hadassah Medical Center in Jerusalem, and a scientific team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of the study is designed to establish the safety of NurOwna" and will later be expanded to assess efficacy.

Patients will be transplanted with stem cells derived from their own bone marrow and treated with Brainstorm's NurOwna" stem cell technology. The trial will include a total of 24 patients, twelve in an advanced stage of the disease and twelve in an early stage. The patients will be examined at regular intervals and followed for six months post transplantation. Additional information regarding the Phase I/II clinical trial is provided by the Hadassah Medical Center at the website: [ http://clinicaltrials.gov/ct2/show/NCT01051882?term=nct01051882&rank=1 ]

About NurOwna"

BrainStorma™s core technology, NurOwna", is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center at the Tel-Aviv University.

The NurOwna" technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF) by means of a specific differentiation-inducing culture medium.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a promising company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. 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. For more information, visit the companya™s website at [ www.brainstorm-cell.com ].

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.