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Posted on: Monday, 31 October 2005, 09:01 CST
BrainStorm Announces Significant Preclinical Benefit of Its GDNF Producing Stem Cells in Animal Models of Parkinson's
BrainStorm Cell Therapeutics (OTCBB:BCLI), today announced that the company's scientific collaborators at Tel Aviv University had successfully implanted human bone marrow derived stem cells into animal models of Parkinson's disease and observed improved motor function within just two weeks of implantation. The beneficial effect was retained for over three months. Worldwide rights to the development and commercialization of the new technology are exclusively licensed to BrainStorm.

The differentiated cells were previously shown to produce a unique protein required for brain cell survival and growth, glial cell line derived neurotrophic factor (GDNF). The GDNF expressing cells, known as astrocytes, were derived by differentiation of human bone marrow stem cells, using the proprietary NurOwn(TM) technology that has been developed by the Company based on discoveries made by Prof. Eldad Melamed and Dr. Daniel Offen of Tel-Aviv University. This technology is exclusively licensed to the Company. In the current study, the cells were transplanted into Parkinson's disease rats, generated by specifically damaging their dopaminergic cells. Within weeks of the transplantation, there was significant improvement in their characteristic disease behavior, including more than 50% reduction in rotational movement and enhancement in their paw reaching capacity.

GDNF capacity to protect a variety of neurons and induce neural sprouting holds great promise for treatment of many neurodegenerative diseases, including Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and even Alzheimer's disease. GDNF has been shown efficacious in restoration of neural function in multiple disease models and its use for human disease is currently being evaluated in clinical trials.

Unfortunately the delivery of GDNF to the disease site is difficult. GDNF is a protein and, as such, has limited stability and brain penetration. Attempts made to deliver the protein directly into the brain have met with limited success. An alternative approach, to deliver GDNF by genetic therapy, suffers the limitations and risks of using viral vectors. Moreover, cell therapeutic approach using either genetically engineered or differentiated embryonic and neural stem cells are limited by issues of graft rejection and potential tumorogenic risk.

BrainStorm's approach of using patient derived differentiated stem cells holds the promise to overcome the above pitfalls. Recognized as the patient's own cells, there should be no graft rejection. Moreover, unlike embryonic cells, the bone marrow derived cells are not known to be tumorogenic. Thus, the newly transplanted cells are expected to survive and integrate, releasing the therapeutic GDNF in a physiological manner.

BrainStorm is also developing patent-pending technology to differentiate human bone marrow into dopamine producing neuron-like cells, which showed functional benefit in animal models of Parkinson's disease. This technology was discovered by the same research team led by Professor Eldad Melamed and Dr. Daniel Offen at Tel Aviv University.

"Harnessing the restorative powers of GDNF is something that has long been sought after by researchers. Our success in reaching this stage of development is phenomenal. Combined with our previous success in producing and implanting dopaminergic cells in animal models, we are now well on the way to providing a two-pronged, synergistic approach to develop long term alternatives for the treatment of Parkinson's disease and other debilitating disorders, such as ALS or SPI," said Prof. Melamed, who acts as Chief Medical Advisor of BrainStorm. "In our quest to provide cures for these debilitating diseases, we are now continuing the work to show that the benefit of the GDNF producing cells in animal models is sustained over time," he added.

"The therapeutic potential of an autologous bone marrow derived stem cell therapy is enormous, and I am very encouraged by our latest results," said Dr. Yaffa Beck, BrainStorm's President & CEO. "Our current efforts are focused to develop our technology into robust, GMP compliant processes, so that our cell products can mature from the preclinical lab into human clinical trials," she added.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is an emerging company developing neural-like stem cell therapeutic products, NurOwn(TM), based on autologous bone marrow derived stromal cells, for treatment of neurodegenerative diseases. NurOwn(TM) patent pending technology is based on discoveries made by the team of prominent neurologist, Prof. Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, at the Felsenstein Medical Research Center of Tel-Aviv University, enabling the differentiation of bone marrow derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. 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. The company's initial focus is on developing treatments for Parkinson's Disease.

About Stem Cell Therapy

Stem cells are non-specialized cells with a remarkable potential for both self-renewal and differentiation into cell types with a specialized function, such as muscle, blood or brain cells. Stem cells may be sourced from fetal or embryonic tissue or from adult tissue reservoirs such as bone marrow. Use of embryonic stem cells, has become the center of significant ethical and moral debate. In contrast, use of adult stem cells does not face the same moral or legal controversy. Stem cell therapy aims to "cure" disease by replacing the 'diseased' cells with 'healthy' cells derived from stem cells. This approach has the potential to revolutionize medicine and, if successful, the implied commercial opportunities are great. Currently, both embryonic stem cells (ESC) and adult stem cells (ASC) are being explored as the potential basis for multiple cell therapy products.

About Parkinson's Disease

Parkinson's Disease (PD), which was first described by James Parkinson in 1817 as "the shaking palsy", is a chronic, progressive neurodegenerative disorder, affecting the brain cells responsible for production of dopamine. The symptoms include tremors, rigidity, slowness of movement and impaired balance. Over four million people in the developed world, including as many as 1.5 million Americans, mainly over the age of 65, are diagnosed with PD. That figure is predicted to rise by 10% by 2010. Pharmaceutical treatments of PD with an estimated combined annual market value of $4 billion, are insufficient to meet patient needs. The search for more effective treatments continues.