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StemCells, Inc. Announces Research Collaboration Focused on Cell-Based Liver Therapy

Posted on: Wednesday, 26 September 2007, 12:00 CDT

StemCells, Inc. (NASDAQ:STEM) today announced that it has entered into a research collaboration with Belgium's Université Catholique de Louvain (UCL) and the UCL-affiliated Cliniques Universitaires Saint Luc (St. Luc Hospital) to further the development of the Company's proprietary human liver engrafting cells (hLEC) as a potential cell-based liver therapy. Under the collaboration, the parties will use UCL-St. Luc Hospital's recently established GMP cell processing facility to optimize procedures to derive hLEC and thereafter, the parties plan to initiate a clinical trial to evaluate the safety and preliminary efficacy of the hLEC as a treatment for children with liver-based metabolic disorders.

The collaboration will be conducted with Etienne Sokal, M.D., Ph.D., professor of medicine and chairman of the department of pediatrics at UCL, director of the pediatric clinical investigation center, the pediatric liver unit and the Pediatric Research Institute, all at UCL-St. Luc Hospital. Prof. Sokal and the liver transplant program at UCL-St. Luc Hospital are among the leaders in researching and developing the transplantation of hepatocyte preparations, a novel alternative to whole organ liver transplants. In addition, the Company notes that UCL-St. Luc Hospital has one of the leading pediatric liver transplant programs in Europe, with over 700 children transplanted since 1984.

"We are very excited to be working with Prof. Etienne Sokal, one of the true pioneers in this developing field. UCL-St. Luc Hospital has an excellent reputation, a strong transplant program, and the vision to establish a GMP facility dedicated to the isolation and preparation of cells for transplantation," said Maria Millan, M.D., F.A.C.S., vice president and head of the Liver Program at StemCells. "This relationship creates a rare convergence of complementary skills and interests which, we believe, advances our mission to develop novel treatments for liver disease."

Prof. Sokal added that most congenital or acquired liver diseases remain progressive despite currently available treatments, and that most of these patients will ultimately need a liver transplant. "Children suffering from liver-based metabolic disorders are at risk for life threatening metabolic crisis and subsequent irreversible damage to the brain or other organs, with deeply affected quality of life," he said. "Liver cell transplantation is a promising treatment alternative, well tolerated and easy to conduct. Based on StemCells' preclinical data demonstrating that the hLEC have more consistent biochemical and metabolic activity compared to hepatocytes, I expect the hLEC will improve the current results of liver cell transplantation. I also expect that this new technology will advance our efforts to treat liver diseases and bring cell transplantation to clinical practice."

"This collaboration with our European colleagues is a wonderful demonstration of how creative strategies can be employed, even across geographic boundaries, to combine the unique expertise and know-how of academic research, clinical practice and the corporate sector in the pursuit of a common goal, which in this case is to accelerate the search for much needed cell-based treatments for a host of severe liver diseases," said Martin McGlynn, president and CEO of StemCells.

Mr. McGlynn added, "Our Liver Program has made significant progress under Maria's leadership and we are very pleased that she has elected to continue her work with us." Dr. Millan recently resigned her positions as Associate Professor of Surgery and Director of Pediatric Kidney & Liver Transplant Programs at Stanford University School of Medicine to continue to lead the Company's Liver Program. "Together with Prof. Sokal and our Belgian colleagues, we look forward to achieving our next goal, which is to initiate a clinical trial with the hLEC in 2008."

About Liver Disease

According to the American Liver Foundation (ALF), 25 million Americans, or about one in every 10, are or have been afflicted with liver, biliary or gallbladder disease. Approximately 27,000 Americans die each year from chronic liver disease and cirrhosis; over 350,000 people are hospitalized each year due to cirrhosis. An estimated 25,000 people are infected with hepatitis C annually, and 10-12,000 people die of it each year. The ALF also estimates that 1.25 million people are chronically infected with hepatitis B, and 5-6,000 people die from the disease each year. At this time organ transplantation is the only available therapy for end-stage liver failure. According to the United Network for Organ Sharing, approximately 5,800 liver transplants were performed in 2004 and 4,600 in 2005. There are currently over 17,000 people waiting for a liver for transplantation, and 1-2,000 people die each year waiting for a transplant.

About hLEC

StemCells, Inc.'s Liver Program is focused on identifying and developing human liver stem and progenitor cells as potential cell-based treatments for damaged or diseased livers. The human liver engrafting cells (hLEC) are a population of cells that are isolated from primary human tissue, engraft in vivo in animals and produce important human proteins that are missing or deficient in liver disease. Because the hLEC are prospectively isolated, they are a defined population of cells with more consistent biochemical and metabolic activity as compared to current hepatocyte preparations. Pre-clinical research findings indicate that the hLEC show promise as a cell-based therapy for the management and treatment of liver diseases.

About StemCells, Inc.

StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of cell-based therapeutics to treat diseases of the central nervous system, liver and pancreas. The Company's programs seek to repair or repopulate neural, liver or other tissue that has been damaged or lost as a result of disease or injury. StemCells has pioneered the discovery and development of HuCNS-SC™ cells, its highly purified, expandable population of human neural stem cells. StemCells is currently conducting a Phase I clinical trial of its proprietary HuCNS-SC™ product as a treatment for neuronal ceroid lipofuscinosis (NCL). NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants and young children. Further information about the Company is available on its web site at: www.stemcellsinc.com.

About Université Catholique de Louvain

The Université Catholique de Louvain, established in Louvain La Neuve and Brussels, Belgium, was founded in 1425 and is one of the oldest universities in Europe. UCL is a global university with graduate study programs in a broad range of fields. UCL has 21,000 students, representing 120 different nationalities, which makes it the largest university of the French community in Belgium. The faculty of medicine is established in Brussels and its distinguished Christian De Duve International Cellular Pathology Institute includes a Nobel Prize-winning researcher. The UCL-affiliated Cliniques Universitaires St. Luc is a modern 900 bed general hospital, and includes a large children's department covering all pediatric subspecialities. The pediatric department, through the Pediatric Clinical Investigation Center and the Pediatric Research Institute, conducts extensive research programs under various regional, national and European funding programs.

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. (the "Company") and its ability to conduct clinical trials as well as its research and product development efforts, such as the Company's research and development of the Company's proprietary hLEC (including their identification, isolation, expansion, engraftment and potential benefits and therapeutic uses) and the research, development and potential commercial use of the Company's proprietary human neural stem cells. The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty whether results obtained in animals transplanted with either the hLEC of HuCNS-SC cells will accurately predict that similar effects can be expected in humans; whether results obtained in animal models of Infantile NCL or other diseases and conditions of the central nervous system or the liver will be able to be translated into treatment for humans; uncertainty as to whether the FDA or other applicable regulators or review boards will permit the Company to continue clinical testing in NCL or will approve future applications to conduct clinical trials of proposed therapies for neurological or liver diseases or other diseases or conditions given the novel and unproven nature of the Company's technology; uncertainties regarding the timing and duration of any clinical trials; uncertainties regarding the Company's ability to obtain the capital resources needed to continue and expand its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty regarding the validity and enforceability of the Company's patents; uncertainty as to whether HuCNS-SC, the hLEC and any products that may be generated in the future in the Company's stem cell programs will prove safe and clinically effective and not cause tumors or other side effects; uncertainty as to whether the Company will achieve revenues from product sales or become profitable; and other factors that are described under the heading "Risk Factors" in Item 1A of the Company's Annual Report on Form 10-K.

Source: Business Wire

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