BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice; Pre-clinical Study Conducted at GLP-compliant Harlan

  BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice;
  Pre-clinical Study Conducted at GLP-compliant Harlan Laboratories

Business Wire

NEW YORK & PETACH TIKVAH, Israel -- January 10, 2013

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 histopathological examinations.

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 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 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 achievements.

Contact:

BrainStorm Cell Therapeutics Inc. (OTC.QB: BCLI)
Dr. Adrian Harel, CEO
Phone: +972-3-9236384
info@brainstorm-cell.com
www.brainstorm-cell.com
 
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