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Andra E. Miller of Biologics Consulting Joins BrainStorm Cell Therapeutics As FDA Consultant

Posted on: Tuesday, 21 August 2007, 09:18 CDT

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that in preparation of a scheduled pre-pre-IND meeting discussion with the FDA, the company has retained the services of the Director of Cell and Gene Therapies of the Biologics Consulting Group, Inc., Dr. Andra E. Miller, as consultant to handle the company's FDA interactions. The purpose of the pre-pre-IND meeting with the FDA is to discuss BrainStorm's planned preclinical strategy in support of the company's Investigative New Drug application (IND). Dr. Miller will serve as BrainStorm's advisor towards the regulatory process with the FDA, and will lead BrainStorm's regulatory efforts for its adult stem cell technologies and therapies for neurodegenerative diseases.

As Gene Therapy Group Leader and Expert Microbiologist in CBER's Division of Cellular and Gene Therapies, Dr. Miller has been very influential in the development of policy in the cell and gene therapy areas. She has actively participated in national and international meetings in the field of gene therapy where she frequently represented the FDA as an invited speaker. "I am excited to be working with BrainStorm, especially during this pivotal moment in the Company's research," said Dr. Miller. "I look forward to being a part of the BrainStorm team, which is working to provide hope to those with neurodegenerative diseases."

"We are very pleased to have Dr. Miller and BCG on board with us. She will, with G-d's help, provide substantial consultation to BrainStorm's preclinical and clinical studies," commented Chaim Lebovits, President of BrainStorm. "Dr. Miller's knowledge and experience with the FDA will help to expedite our efforts and research. Brainstorm is aware that its forthcoming application will be one of the first autologous stem cell-based therapies to be reviewed by the Agency. Dr. Miller has been an international thought leader, during her government career and subsequently in the most effective approaches to protecting public safety while bringing new cell-based therapies to market that may preserve and enhance the lives of millions. BrainStorm's preclinical research related to Parkinson's disease has reached the stage where we are ready to approach the FDA about initiating clinical Phase I trials."

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.

Source: Business Wire

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