FDA Approves Commencement of BrainStorm's Phase II ALS Clinical Trial in U.S.

FDA Approves Commencement of BrainStorm's Phase II ALS Clinical Trial in U.S. 
NEW YORK, NY and PETACH TIKVAH, ISRAEL -- (Marketwired) -- 04/28/14
--  BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer
of adult stem cell technologies for neurodegenerative diseases,
announced today that the US Food and Drug Administration (FDA) has
approved commencement of its Phase II clinical trial with NurOwn(TM)
in patients with Amyotrophic Lateral Sclerosis (ALS). The trial will
be launched initially at the Massachusetts General Hospital (MGH) in
Boston, MA and the University of Massachusetts Memorial (UMass)
Hospital in Worcester, MA following Institutional Review Board (IRB)
approvals. Dana-Farber Cancer Institute's Connell O'Reilly Cell
Manipulation Core Facility will manufacture the NurOwn(TM) cells for
these two clinical sites. The trial will also be conducted at the
Mayo Clinic in Rochester, Minnesota. 
"Today's announcement represents the most significant milestone
BrainStorm has achieved to date," said Mr. Chaim Lebovits, President.
"More importantly, in our view, it has positive implications for the
entire ALS community, indicating that the FDA recognizes the
significant clinical potential of transplantation with our
autologous, differentiated mesenchymal stem cells. We are excited to
begin the US trial and are optimistic that the Phase II data will
confirm the positive indications of clinical benefit we observed in
earlier studies. This trial will be the first Phase II double-blinded
stem cell study to be conducted for ALS." 
"Following successful completion of the technology transfer process
for BrainStorm's NurOwn cells, we are looking forward to
collaborating on this multi-center study as the cell production
facility for the Massachusetts clinical sites," added Professor
Jerome Ritz, Department of Medicine, Harvard Medical School, and
Director, Connell O'Reilly Cell Manipulation and Gene Transfer
Laboratory, Dana-Farber Cancer Institute. 
BrainStorm's Phase II trial is a randomized, double-blind, placebo
controlled multi-center study designed to evaluate the safety and
efficacy of transplantation of Autologous Mesenchymal Stem Cells
Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn(TM)) in 48 ALS
patients. The NurOwn(TM) cells will
 be administered via combined
intramuscular and intrathecal injection. Patients will be followed
monthly for approximately three months before transplantation and six
months following transplantation. The primary objective of the study
will be safety and tolerability, as defined by a measure of the
number of patients with adverse events. Secondary endpoints will
measure a change in the Amyotrophic Lateral Sclerosis (ALS)
Functional Rating Scale (ALS-FRS) and a change in Slow Vital Capacity
(SVC) slopes. For further details, please go to
http://1.usa.gov/1l5XWkW. 
Earlier clinical trials have shown that treatment with NurOwn(TM)
cells was well tolerated and safe. According to the final clinical
study report for BrainStorm's Phase I trial in Israel, the study
successfully met its primary and secondary endpoints. Moreover, there
were "encouraging signals of efficacy in individuals receiving NurOwn
treatment, in which a dramatic improvement was observed during more
than two consecutive visits following treatment in one or more of
their secondary efficacy endpoints (ALSFRS-R score, total
neurological examination score, FVC, and CMAP). Initial observations
of the company's Phase IIa trial data in Israel appear to reinforce
these findings. An interim update is expected to be released later
this quarter.  
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. 
Contacts
BrainStorm Cell Therapeutics Inc. 
(OTC.QB: 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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