BrainStorm Submits Favorable Interim Safety Report for First Group of Patients
in Its Phase IIa Dose-Escalating Trial
NEW YORK, NY and PETACH TIKVAH, ISRAEL -- (Marketwired) -- 06/05/13
-- BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer
of adult stem cell technologies for neurodegenerative diseases, today
announced that it has submitted a favorable safety report to the
hospital Helsinki Committee (IRB) for the first group of patients in
its ongoing Phase IIa ALS clinical trial at the Hadassah Medical
Center in Jerusalem, Israel. The company will release the preliminary
efficacy data at the conclusion of the trial.
In this Phase IIa dose-escalating trial, currently underway at
Hadassah under the direction of Principal Investigator Professor
Dimitrios Karussis, 12 ALS patients are receiving combined
intramuscular (IM) and intrathecal (IT) administration of NurOwn
cells, in three cohorts, with increasing doses. The study
participants will be monitored for six months following
"In the previous Phase I study recently completed at our clinic, the
trial participants received NurOwn(TM) cells via a single route of
administration only," explained Professor Karussis. "In this study,
the patients are receiving treatment both IM and IT, so even the
patients in the low dose group received many more cells than in the
previous study," he added.
About BrainStorm Cell Therapeutics, Inc.
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 achievements.
BrainStorm Cell Therapeutics Inc.
Mr. Alon Natanson
LifeSci Advisors, LLC
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