|[January 09, 2013]
BrainStorm Achieves Important New Development for Commercialization of NurOwn
NEW YORK & PETACH TIKVAH, Israel --(Business Wire)--
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult
stem cell technologies for neurodegenerative diseases, announced today
that it has achieved a new breakthrough for commercialization of its
stem cell therapy candidate, NurOwn. The company has developed a
proprietary method for cryopreservation, or freezing, of cells, which
will enable long-term storage, and production of repeat patient doses of
NurOwn without the need for additional bone marrow aspirations.
"Cryopreservation will enable us to create a personalized NurOwn stem
cell bank for each patient, for ongoing, repeat treatments," commented
Dr. Adrian Harel, BrainStorm's CEO. "We will be in a position to produce
repeat doses of NurOwn by thawing and processing the patients'
cryopreserved cells, and transporting these doses to medical centers for
Cryopreservation of hematopoeitic (or blood cell-forming) stem cells for
clinical use has been routinely performed for fifteen years.
Cryopreservation of mesenchymal stem cells for clinical use is a more
recent phenomenon, and is typically done in vapor phase nitrogen. At
extreme, sub-zero temperatures, any biological activity, including the
biochemical reactions that would cause cell death, is effectively
According to Harel: "Our unique method of expansion and differentiation
of mesenchymal stem cells requires its own cryopreservation methodology.
The company's R&D team has been focused on this aspect of product
development in recent months in order to be fully prepared for repeat
dosing of ALS patients."
BrainStorm is currently launching a Phase IIa combined treatment,
dose-escalating dose trial of its NurOwn cell therapycandidate in ALS
patients at the Hadassah Medical Center in Jerusalem. The company was
recently fast-tracked by the Israeli Ministry of Health after reporting
positive safety data for 12 patients in a Phase I/II trial.
BrainStorm is planning to expand its ALS clinical development to the
United States, pending FDA approval. Towards that goal, the Company has
entered into a Memorandum of Understanding with the University of
Massachusetts Medical School and Massachusetts General Hospital to begin
ALS human clinical trials at these institutions.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in
the development of first-of-its-kind adult stem cell therapies derived
from autologous bone marrow cells for the treatment of neurodegenerative
diseases. The Company holds the rights to develop and commercialize its
NurOwn technology through an exclusive, worldwide licensing agreement
with Ramot, the technology transfer company of Tel Aviv University. For
more information, visit the company'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. Terms and phrases such as "may", "should",
"would", "could", "will", "expect", "likely", "believe", "plan",
"estimate", "predict", "potential", and similar terms and phrases
are intended to identify these forward-looking statements. The
potential risks and uncertainties include, without limitation, 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.
These factors should be considered carefully, and readers should not
place undue reliance on BrainStorm's forward-looking statements. The
forward-looking statements contained in this press release are based on
the beliefs, expectations and opinions of management as of the date of
this press release. We do not assume any obligation to update
forward-looking statements to reflect actual results or assumptions if
circumstances or management's beliefs, expectations or opinions should
change, unless otherwise required by law. Although we believe that the
expectations reflected in the forward-looking statements are reasonable,
we cannot guarantee future results, levels of activity, performance or
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