Positive Interim Phase IIa ALS Data With BrainStorm's NurOwn Presented at Joint Congress of European Neurology

Positive Interim Phase IIa ALS Data With BrainStorm's NurOwn Presented at Joint 
Congress of European Neurology 
Latest Results Reinforce Earlier Study Data 
NEW YORK, NY and PETACH TIKVAH, ISRAEL -- (Marketwired) -- 06/02/14
--  BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) today announced
that interim results from the Company's Phase IIa ALS trial conducted
at Hadassah Medical Center in Jerusalem, Israel were presented
yesterday at the Joint Congress of European Neurology by Principal
Investigator Professor Dimitrios Karussis. The positive safety and
preliminary efficacy results observed in this study are consistent
with results observed in the company's previous Phase I/II trial.
Between these two studies, a total of 26 patients have been treated
with NurOwn(TM), BrainStorm's stem cell therapy candidate for ALS.  
Prof. Karussis summarized the results from both phases of the ALS
clinical trial, and presented an interim analysis of the data for the
first 10 out of 14 patients in the current Phase IIa trial. Results
from the last four patients will be analyzed following completion of
their six month follow-up period. In all 26 patients who received
NurOwn(TM) in the two trials, no treatment-related serious adverse
events were observed. In the three month pre-treatment "run-in"
period, 71% of the patients showed progression of disease with
decline in neurological function. In contrast, in the three months
post-transplantation with NurOwn(TM), 63% of the patients who
received intrathecal (IT), or combined (IT) and intramuscular (IM)
administration, showed stabilization or improvement in neurological
function, as measured by their revised ALS functional rating score
(ALSFRS-R). According to Prof. Karussis, these differences in the
preliminary analysis were statistically significant at p=0.035,
chi-square test.  
Additionally, as Prof. Karussis mentioned in his presentation, in
both phases of the trial, 63% of the patients treated with NurOwn(TM)
via IT or combined IT and IM administration were defined as
"responders" (slower progression of disability or improvement in
their neurological function) at 3 months post-treatment, based on
both their ALSFRS-R score and Forced Vital Capacity (FVC), an
indication of respiratory function. The six patients treated with
NurOwn(TM) in the earlier Phase I/II trial via IM administration
only, primarily exhibited a localized positive effect. Similarly, in
the same Phase I/II trial, the IT transplanted patients also showed
indications of neurotrophic and regenerative effects, as evidenced by
an increase in Compound Muscle Action Potential (CMAP) in the treated
arm.  
Prof. Karussis noted, "Administration of NurOwn was well tolerated
both intramuscularly and intrathecally. I am very encouraged by signs
of disease stabilization and even improvement that we observed in a
number of the treated subjects. Analysis of the complete dataset will
be invaluable in helping BrainStorm optimize the analysis of its
Phase II study, which is about to launch in the United States."  
"We are very satisfied with the results observed so far in these two
studies," commented Chaim Lebovits, BrainStorm's President. "The fact
that some of the patients actually demonstrated clinical improvement
surpassed our expectations of achieving stabilization or reduced rate
of decline. We look forward to the completion of this trial and to
building on these results in our double-blind, placebo controlled,
multi-center study currently being launched in the USA." 
About NurOwn(TM)
 NurOwn is an autologous, adult stem cell therapy
technology that differentiates bone marrow-derived mesenchymal stem
cells (MSC) into "MSC-NTF" cells. These neuron-supporting cells
secrete elevated levels of neurotrophic, or nerve-growth, factors for
PROTECTION of existing motor neurons, PROMOTION of motor neuron
growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The ability
to differentiate mesenchymal stem cells into MSC-NTF cells, and
confirmation of their activity and potency before transplantation,
makes NurOwn a first-of-its-kind approach for treating
neurodegenerative diseases. More information about NurOwn(TM) can be
found at
http://brainstorm-cell.com/index.php/science-a-technology/-nurown. 
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. (OTCQB: BCLI)
Mr. Chaim Lebovits
President
Phone: +972-3-9236384
info@brainstorm-cell.com  
US Investor Contact
LifeSci Advisors, LLC
Michael Rice
Phone: 646-597-6979
mrice@lifesciadvisors.com 
 
 
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