First Patient Begins Treatment in BrainStorm’s Phase IIa Trial for ALS
NEW YORK & PETACH TIKVAH, Israel -- February 4, 2013
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem
cell technologies for neurodegenerative diseases, announced today that the
first patient began treatment in the Company’s Phase IIa dose-escalating
clinical trial for ALS. The trial, which will evaluate the safety and
preliminary efficacy of BrainStorm’s NurOwn stem cell therapy candidate, is
being conducted at the Hadassah Medical Center in Jerusalem.
In the Phase IIa trial, three groups of four patients will receive combined
intramuscular and intrathecal administration of NurOwn cells, in increasing
doses. The first cohort of four patients is expected to complete treatment by
the end of April 2013. The trial participants will be monitored for three to
six months following transplantation.
“We are excited to be treating the first patient in this trial, which will
build on the excellent safety profile and encouraging positive results from
our Phase I/II study,” commented Alon Natanson, BrainStorm’s CEO.
“This trial will provide valuable data not only on the safety of NurOwn in ALS
patients, but also on the ability of different dosing levels to provide
clinical benefit,” added Prof. Dani Offen, the Company’s Chief Scientific
Israel’s Ministry of Health recently approved BrainStorm’s acceleration to a
Phase IIa trial following the positive safety evaluation of the first 12
patients in the company’s recent Phase I/II trial at Hadassah. A description
of the trial can be found at:
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 achievements.
BrainStorm Cell Therapeutics Inc. (OTC.QB: BCLI)
Mr. Alon Natanson, CEO
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