Message #21 From:
The Machine Date: February 16, 2008 02:12:43 AM
BrainStorm Cell Therapeutic on the road to Clinical Studies in Parkinson's Disease
Company Reports Preliminary Results from Safety Supporting Study in Primates
NEW
YORK & PETACH TIKVAH, Israel – August 14, 2007 – BrainStorm Cell
Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell
technologies and therapeutics, is pleased to announce preliminary
results from its first safety supporting experiment. On February 8,
2007 in laboratories at the University of Navarra, Pamplona, Spain,
Prof. Jose Obeso transplanted the subject, a healthy monkey, with
BrainStorm`s human bone marrow derived mesenchymal stem cells.The
stem cells had been induced to differentiate into neurotrophic
factor-producing cells, according to the protocol developed at the
Company`s laboratories in Israel.
The
monkey was treated daily with cyclosporine to prevent rejection of the
human originating cells by its immune system, and was monitored for a
variety of parameters for a period of three months. Throughout this
phase, the monkey appeared well and in good health, with a usual
appetite, and with no apparent change in physical and behavioral
parameters. Blood tests, an MRI of the monkey’s brain and an autopsy
examination of the internal organs were also found to be normal.
Additionally, brain tissues from the monkey were examined by Prof. Jeffrey Kordower (RushUniversity, Chicago, USA).
A few human originating cells were detected in sections of the monkey’s
brain by staining the sections with an antibody, which can distinguish
between the monkey’s own brain cells and the human transplanted cells.
The human transplanted cells were surrounded by macrophages, which may
indicate a reaction of the monkey’s immune system to the transplanted
human cells and their initial rejection. BrainStorm`s actual approach
would involve autologous transplantation (i.e., the use of the
patient’s own bone marrow-derived stem cells). With this strategy, no
rejection is expected and there will be no need to suppress the immune
system by medications that often cause severe side effects.
"We are extremely pleased with the faster pace and direction in which the Company is now moving," commented Chaim Lebovits, President of BrainStorm. "The
recent financing the Company has received will, with G-d's help, allow
BrainStorm to move forward with the preparations necessary toward
carrying out Phase I/II clinical trials in patients with Parkinson's
disease, and providing the funding and support needed to conductadditional safety pharmacology studies, such as toxicology."
Two additional normal monkeys recently underwent transplantation in Pamplona
with BrainStorm’s human stem cells. The monkeys will also be monitored
for a period of three months for collection of additional data; so far,
the monkeys are in good 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 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 RabinMedicalCenter,
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-AvivUniversity.
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.
SafeHarbor 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.