WEINHEIM, Germany, Oct. 19, 2011 /PRNewswire/ -- The Canadian health authority, Health Canada, recently granted Cytonet approval to extend the SELICA III trial, which has been open in the United States since 2010, into Canada.
The clinical trial is designed to evaluate the safety and efficacy of liver cell therapy in infants to children up to age 5 with urea cycle disorders (UCD). Two centers in Canada join the 12 medical centers in the United States taking part in the trial: the Alberta Children's Hospital in Calgary and the Hospital for Sick Kids in Toronto.
"Adding centers in Canada will help us achieve our goal of enrolling 20 children in the trial and more widely offers a much-needed new option for a very serious condition where the only current cure is liver transplantation," says Dr. Wolfgang Rudinger, CEO and CSO of Cytonet Germany.
UCDs are congenital and often life-threatening disorders of ammonia metabolism in the liver. Neurotoxic ammonia accumulates in the body and may lead depending on the severity of the disease to massive damage of the nerves and the brain and can be fatal.
For more information, please visit Cytonet's website at http://www.cytonetllc.com/
About the SELICA (Safety and Efficacy of Liver Cell Application) Study
For the past several years Cytonet has worked with internationally-leading metabolism and neonatal centers to study its liver cell treatment. This therapy uses healthy and metabolically functional human hepatocytes for infusion to treat the metabolism disorder. Healthy cells from donated livers not suitable for transplantation (obtained from U.S. organ procurement organizations) are isolated and undergo complex processing. These cells are infused into the hepatic portal vein over six days.
In July 2010, the FDA permitted clinical testing to proceed in the SELICA III trial. The FDA was provided with an analysis of interim results of an ongoing trial (SELICA V) in Germany among newborns with UCDs. Cytonet would like to acknowledge the National Urea Cycle Disorders Foundation for its assistance during the development of the program. For more information about urea cycle disorders, visit the National Urea Cycle Disorders Foundation at www.nucdf.org
About Urea Cycle Disorders
According to the National Urea Cycle Disorders Foundation (NUCDF), a urea cycle disorder is a genetic disorder caused by a deficiency of one of the six enzymes in the urea cycle which is responsible for removing ammonia from the blood stream. These include carbamoyl phosphate synthetase I (CPS I) deficiency, N-acetylglutamate synthetase (NAGS) deficiency, ornithine transcarbamylase (OTC) deficiency, argininosuccinate synthetase (ASS) deficiency (which is also known as citrullinemia), argininosuccinate lyase (ASL) deficiency and arginase 1 deficiency (hyperargininemia). The urea cycle involves a series of biochemical steps in which nitrogen, a waste product of protein metabolism, is removed from the blood and converted to urea. Normally, the urea is transferred into the urine and removed from the body. In urea cycle disorders, the nitrogen accumulates in the form of ammonia, a highly toxic substance, and is not removed from the body resulting in hyperammonemia (elevated blood ammonia). Ammonia then reaches the brain through the blood, where it causes irreversible brain damage, coma and/or death.
Urea cycle disorders are included in the category of inborn errors of metabolism. Inborn errors of metabolism represent a substantial cause of brain damage and death among newborns and infants. Because many cases of urea cycle disorders remain undiagnosed and/or infants born with the disorders die without a definitive diagnosis, the exact incidence of these cases is unknown and underestimated. It is believed that up to 20 percent of Sudden Infant Death Syndrome cases may be attributed to an undiagnosed inborn error of metabolism such a urea cycle disorder. Experts estimate the incidence of the disorders at 1 in 10,000 births. This represents a significant increase in case identification and diagnosis in the last few years. Research studies have now been initiated to more accurately determine the incidence and prevalence of UCDs. For more information, please visit NUCDF at www.nucdf.org
The Cytonet Group is an internationally active biotechnology company which is located in Weinheim and Heidelberg in Germany and in Durham, North Carolina in the U.S. The company develops, produces and markets cell therapeutic products. By using specially prepared human cells, it is possible to provide alternatives to existing therapies for many diseases. In addition, Cytonet provides blood stem cells and bone marrow preparations for the treatment of leukemia and other tumor diseases. The managing directors are Dr. Wolfgang Rudinger and Michael J. Deissner. Cytonet was founded as a result of the demerger of the cell therapy division from the firm of Roche in April 2000. The controlling interest is held by the family of Dietmar Hopp. The project is supported by the German Federal Ministry for Education and Research (BMBF) as part of the Leading Edge Cluster Competition (Spitzencluster Wettbewerb). Cytonet is an active partner in the Biotech-Cluster-Rhein-Neckar (BioRN) - the Rhine Neckar biotechnology cluster, which was designated in 2008 as the leading edge cluster in "cell-based and molecular medicine."
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