StemCells, Inc. to Present Preclinical Data Showing Engraftment of Human Liver-Derived Cells at the World Transplant Congress
Promising Cellular Therapy Candidate for the Treatment of Liver Disease
PALO ALTO, Calif., July 20, 2006 - StemCells, Inc. (NASDAQ: STEM) today announced that Maria Millan, M.D., F.A.C.S., Director, Liver Cell Transplant Program, is scheduled to present a paper at the World Transplant Congress at 11:10 a.m. on Tuesday, July 25, 2006. This year's World Transplant Congress is being held July 22-27, 2006 at the Hynes Convention Center in Boston, Massachusetts.
Dr. Millan's paper, entitled "Long-term Engraftment of Human Liver-derived Stem/Progenitor Cells," will demonstrate that a population of human liver engrafting cells (hLEC) identified and isolated by StemCells, Inc., engraft in animal models and produce important human proteins that are missing or deficient in liver disease. These findings indicate that the hLEC shows promise as a cellular therapy candidate for the management and treatment of liver diseases. The liver program at StemCells is focused on identifying and developing human liver stem and progenitor cells as potential cellular therapies or therapeutic agents to treat damaged or diseased livers. StemCells has previously demonstrated a reliable method for the prospective identification and isolation of hLEC, and has more recently demonstrated that hLEC can be obtained from livers that are not suitable for use in whole organ transplants.
“The ability to retrieve liver cells with therapeutic potential from livers that cannot be used for transplantation could have two major benefits. First, it offers the possibility of turning donated organs that would otherwise have to be discarded into a source of therapeutic benefit,” said Dr. Millan. “In addition, liver cellular therapy may offer an alternative to whole liver transplantation, which would help relieve the shortage of donor organs. Pioneers in the field of ‘hepatocyte transplantation’ have demonstrated early promise of cellular therapy. As part of the overall mission to offer defined and reliable cellular products for transplantation, we are seeking to evaluate hLEC as such a product for the treatment of conditions requiring liver replacement therapy.”
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. Organ transplantation is the only available therapy for end-stage liver failure at this time. 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 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 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 is the first company to directly identify and isolate human neural stem cells from normal brain tissue. These cells are expandable into cell banks for therapeutic use, which offers the potential of using normal, non-genetically modified cells as cell-based therapies. StemCells recently initiated a Phase I clinical trial of its proprietary human neural stem cells (HuCNS-SC™) as a treatment for neuronal ceroid liposfucinosis (NCL). NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants and young children. StemCells has approximately 40 U.S. and 100 non-U.S. patents. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical facts, 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; and the Company’s research and development of the 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 the hLEC will prove therapeutic in animal models of liver diseases; whether results obtained in animals transplanted with the hLEC 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 liver disease or other diseases or conditions despite 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.
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CONTACT: StemCells, Inc.
Rodney Young
Chief Financial Officer
650-475-3100, Ext. 105
irpr@stemcellsinc.com
or
Schwartz Communications, Inc.
781-684-0770
stemcells@schwartz-pr.com
SOURCE: StemCells, Inc.
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