|[January 06, 2014]
Significant Clinical Findings on ALS Patient Treated with BrainStorm's NurOwn Featured in "Muscle and Nerve"
NEW YORK & PETACH TIKVAH, Israel --(Business Wire)--
BrainStorm Cell Therapeutics Inc. (OTC.QB: BCLI), a leading developer of
adult stem cell technologies for neurodegenerative diseases, today
announced the upcoming publication of a case report on an individual
patient treated with the company's NurOwn™ cell therapy in "Muscle &
Nerve" (John Wiley & Sons (News - Alert)). The report, which looked at one patient
diagnosed with both Myasthenia Gravis (MG) and Amyotrophic Lateral
Sclerosis (ALS) showed significant improvements in both cognitive and
motor function following initial and repeat treatments with NurOwn.
The paper, entitled "Rare Combination of Myasthenia and ALS, Responsive
to MSC (News - Alert)-NTF Stem Cell Therapy" by Professors D. Karussis, Z. Argov, O.
Abramsky and their colleagues at Hadassah University Medical Center in
Jerusalem, as well as Professor V. A. Lennon from Mayo Clinic in
Rochester MN, describes the rare case of a 75-year old man diagnosed
with MG and ALS who was treated with NurOwn cells on a compassionate
basis. One month after receiving both intrathecal and intramuscular
injections of the cells, the patient demonstrated significant
improvement in cognition, speech, and muscle power. Initial therapy led
to improvement in the ALS Functional Rating Scale (ALSFRS-R),
respiratory forced vital capacity (FVC) and cognitive function.
Following therapy, the patient's ability to speak improved from
dysarthria to being able to deliver a speech clearly to an audience.
At 6 months post-transplantation, due to progression of weakness and
deterioration in cognition, a repeat injection of Brainstorm's NurOwn,
was performed. Again, improvements in ALSFRS-R and respiratory forced
vital capacity (FVC) were observed following second treatment. Treatment
with NurOwn appeared safe and well tolerated; the patient did not
experience any serious adverse events after either course of treatment.
The results suggest that repeated therapy may maintain and enhance the
clinical benefits of NurOwn cell therapy in neurological diseases. The
authors stated that "the outcome of the second transplantation was even
more remarkable." They noted that laboratory and clinical improvements
of the magnitude observed are "highly unusual in the natural course of
ALS." They speculated that "repeated transplantation might be needed to
maintain and enhance the clinical benefits of stem cell therapies," and
that "the improvement in many functional parameters suggest that the
motor nerve function may have been more significantly affected by the
treatment than MG."
Chaim Lebovits, BrainStorm's President, commened on the results, "This
report is very promising and this unique case provides insights into the
possible effects of repeat treatments of MSC-NTF cell transplantation on
ALS. This publication is an important milestone for BrainStorm as this
is the first human data on NurOwn to be published in a highly respected
scientific journal. While our PI already reported positive and promising
safety and efficacy data from our Phase I/II clinical trial, we look
forward to finalizing our ongoing Phase IIa clinical trial data and thus
announce the combined data. Together, these data will include a total of
26 patients with ALS."
A preview of the paper is available at this link.
NurOwn™ is a proprietary, first-of-its-kind technology that induces
autologous bone marrow-derived Mesenchymal Stem Cells (MSCs) to secrete
Neurotropic Factors (NTF). The NurOwn treatment approach is to
transplant these "MSC-NTF" cells back into the patient at or near the
site of damage, in the spine and/or muscles.
Brainstorm Cell Therapeutics is currently conducting a Phase IIa ALS
clinical trial with NurOwn at the Hadassah University Medical Center in
Jerusalem. In this safety and preliminary efficacy trial, 12 patients
will receive combined intramuscular and intrathecal administration of
NurOwn cells in three cohorts with increasing doses. The study
participants are being followed for six months after transplantation.
The Company also plans to begin a Phase II clinical trial in the US in
early 2014, pending FDA approval.
NurOwn was granted Orphan Drug designation by the US FDA and the
European Commission (EC). Over 20 publications in leading scientific
journals demonstrating NurOwn's mechanism of action, pharmacology and in
vivo efficacy have been published by the Company's scientific team.
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
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