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BrainStorm's NurOwn Stem Cell Technology Shows Promise for Treating Sciatic Nerve Injury

Positive Preclinical Results Published in Stem Cell Reviews and Reports

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--Feb 23, 2011 - BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that intramuscular transplantation of autologous, astrocyte-like cells that produce and secrete neurotrophic factors (NTFs), representing the company's NuOwn™ technology platform, preserved motor function, significantly inhibited the degeneration of the neuromuscular junctions (NMJs), and preserved the myelinated motor axons in an animal sciatic nerve injury model. Results of the study appear in the online edition of the journal Stem Cell Reviews and Reports.

“The findings from this study demonstrating that BrainStorm's autologous NurOwn™ stem cell therapy can alleviate signs of sciatic nerve injury is an important milestone for the company,” said Chaim Lebovits, President of BrainStorm. “One of the major caveats of stem cell transplantation is the fate of the transplanted cells. In the current study, we show that our transplanted cells can integrate and survive in the host muscles of animals after sciatic nerve crush for at least 3 weeks. This preclinical work provides additional support for the upcoming Phase 1 clinical trial of NurOwn™ for patients with amyotrophic lateral sclerosis (ALS) and other neurological disorders.”

In a study conducted at Tel Aviv University, mesenchymal stem cells (MSCs) isolated from the femurs and tibias of adult rats were developed into NurOwn™ using a two-step medium based differentiating protocol to induce the MSCs into NTF secreting cells. These cells produce and release high amounts of NTFs, such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF). The NTF secreting cells (NurOwn™) were labeled with superparamagnetic iron oxide (SPIO) to enable tracking of surviving cells following injection into the muscles of the right hind limb 24-hours after sciatic nerve crush.

Four days after transplantation, there was a statistically significant beneficial effect on the motor function in the NurOwn™ treated animals compared to the control rats, which did not receive cell transplants, or rats transplanted with non-differentiated MSCs. The high compound muscle action potential and low latency indices recorded in the hind limb muscles of NurOwn™ treated animals provided evidence that NurOwn™ preserved the myelinated motor axons and innervated peripheral muscles. Histology of the animal's hind limb muscles 3-weeks after transplantation revealed significant amount of pre-labeled NurOwn™ cells and high levels of BDNF in the muscles.

About Sciatica

One of the most common peripheral neuropathy is sciatica, damage to the sciatic nerve, with a high reported prevalence. Sciatica is characterized by muscle weakness, reflex changes and numbness. Tumors, cysts or other extraspinal insults can cause sciatica. The majority of sciatica patients suffer from persistent and severe types of pain, motor dysfunctions and prolonged disability.

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. According to the ALS Association, approximately 5,600 people in the U.S. are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time. The financial cost to families of patients is exceedingly high, and it is estimated that in the advanced stage, care can cost an average of $200,000 per year, which represents more than a $6 billion cost to the healthcare system.

About NurOwn™

BrainStorm's core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson's Research, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center (FMRC) at the Tel-Aviv University.

The NurOwn™ technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn™ technology highly attractive for treating ALS and Parkinson's disease as well as MS and spinal cord injury.

BrainStorm's stem cell therapy contains human mesenchymal stromal cells induced to differentiate into astrocyte-like cells secreting neurotrophic factors by means of a specific differentiation-inducing culture medium.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is an emerging company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., 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. The potential risks and uncertainties include 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. The Company does not undertake any obligation to update forward-looking statements made by us.

Contact: Company Contact:
BrainStorm Cell Therapeutics
Adrian Harel, Ph.D., COO and Acting CEO
+972-3-9236384
aharel@brainstorm-cell.com
or
Investors/Media Contact:
MD Becker Partners LLC
Michael Becker, Senior Partner
+1-267-756-7094
michael@mdbpartners.com

 

Posted: February 2011

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