MMA for Urea Cycle Disorders filed in EU-Cytonet
Cytonet has announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) seeking approval of its liver cell therapy treatment for Urea Cycle Disorders (UCD) in children. Liver cell therapy involves collecting healthy cells from donated livers not suitable for transplantation which are then gently isolated and undergo complex processing. These cells are infused into the portal vein over six days.
Cytonet is conducting a Phase II clinical trial in the US and Canada (SELICA III) designed to test the safety and efficacy of liver cell therapy in infants to children up to five years old with UCD. SELICA III is currently enrolling patients at 11 sites in the United States and Canada. Cytonet received orphan drug status in the US in 2011.
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