Message #14 From:
Stock News Bot Date: September 26, 2007 06:35:38 AM
BrainStorm Cell Therapeutics Takes Initial Steps Toward FDA Submission
BrainStorm Conducts Positive Preliminary Meeting With Representatives
of CBER, FDA
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.
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.
for BrainStorm Cell Therapeutics Inc. Alison Crisci,
212-584-4305 acrisci@5wpr.com
