Healthcare Industry News: neurodegenerative
News Release - September 10, 2007
BrainStorm Cell Therapeutics Takes Initial Steps Toward FDA SubmissionBrainStorm Conducts Positive Preliminary Meeting With Representatives of CBER, FDA
NEW YORK & PETACH TIKVAH, Israel--(HSMN NewsFeed)--BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI ), a developer of autologous adult stem cell technologies and therapeutics, announced today that the Company has completed a preliminary meeting with representatives of the FDA Office of Cellular, Tissues and Gene Therapies, to discuss BrainStorm's preclinical research program in Parkinson's Disease. The meeting was a prelude to a future IND filing for entering human trials in the area of Parkinson's Disease. FDA representatives addressed the results of the Company's four month data in a murine Parkinson's model and the Company's basic approach to preclinical proof of concept. FDA suggested confirmatory studies in a second species of experimental animals to provide more data on safety and efficacy of the procedure, before the initiation of human trials. Since the meeting was voluntary from a regulatory perspective, no PDUFA clocks attach to the next phase of contact between the Company and FDA.
"We are extremely pleased with the collegial reception afforded by the FDA staff," said Prof. Eldad Melamed, Brainstorm's founder and chief scientist. "Because our scientific direction is based upon autologous (i.e. derived from the patient to be treated) adult stem cells, several of the well-known concerns that FDA has in the past expressed regarding stem cell therapies were much less of a factor in our conversation."
"We hope that this next stage of our study will with G-d's help provide the most effective approaches to protecting public safety while advancing the goal of ultimately bringing BrainStorm's new cell-based therapies to market to preserve and enhance the lives of millions," said Mr. Chaim Lebovits, Brainstorm's President.
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 astrocyte-like cells, secreting a variety of growth factors essential for brain cell survival, 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: BrainStorm Cell Therapeutics
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