|[January 10, 2013]
BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice; Pre-clinical Study Conducted at GLP-compliant Harlan Laboratories
NEW YORK & PETACH TIKVAH, Israel --(Business Wire)--
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of
adult stem cell technologies for neurodegenerative diseases, announced
that it has successfully completed a 12-week repeat dose toxicity study
with its NurOwn cells in mice. The company believes that the positive
data from the study will support its efforts to obtain approval for a
future repeat dose clinical study in ALS patients. The study was
conducted at Harlan Israel's laboratories, according to GLP (Good
Laboratory Practice) standards of the FDA. The study protocol was
approved by the Israeli Ministry of Health.
"We believe that repeat dosing is the key to the long-term clinical
efficacy of NurOwn and we are anxious to begin testing in ALS patients.
Our proprietary cryopreservation protocol will enable us to do so
without having to perform repeat bone marrow aspirations for each dose,"
commented Dr. Adrian Harel, BrainStorm's CEO.
In the study, the animals received up to three intramuscular injections
of NurOwn, produced from cryopreserved, or frozen, cells at
concentrations 50-100 times the currently administered clinical trial
dose. The treatment was well tolerated, and no adverse clinical effects
were observed. Analyses included cytokine profile assays, clinical
pathology, necropsy and macroscopic examination, as well as
BrainStorm is currently launching a Phase IIa combined treatment,
dose-escalating trial of its NurOwn cell therapy candidate in ALS
patients at the Hadassah Medical Center in Jerusalem. The company was
recently fast-tracked by the Israeli Ministry of Health after reporting
positivesafety data for 12 patients in a Phase I/II trial.
BrainStorm is planning to expand its ALS clinical development to the
United States in 2013, 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 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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