FDA approves innovative liver cell therapy for clinical trial in the U.S.
August 6, 2010 – On July 23, 2010 the liver cell preparation by Cytonet GmbH & Co. KG received an Investigational New Drug allowance (IND) from the U.S Food and Drug Administration (FDA). This is the first time a later stage clinical trial with liver cell therapy can now be started in the US. The FDA-approval is partly based on interim results of an ongoing clinical trial in Germany with neonatal patients suffering from urea cycle disorders (UCD). Cytonet will immediately start the clinical trial SELICA (Safety and Efficacy of Liver Cell Application)-III. The objective of this open, prospective, group-matched, historic-controlled multi-center study is to investigate the safety and efficacy of liver cell therapy in children suffering from UCD. Five therapy centers, as well as 10 centers actively assigning patients and responsible for the after-care, are participating in the SELICA-III trial.
This study is the second clinical study on liver cell therapy in children suffering from UCD. The first trial, SELICA-II, has been running in Germany for approximately 1 year. SELICA-III comprises a six-month treatment and observation phase and a subsequent 18-month follow-up. The study includes infants, toddlers and children up to the age of five, who are suffering from the most severe forms of the following UCDs: ornithine transcarbamylase (OTC) deficiency, carbamoylphosphate synthetase I (CPS I) deficiency or argininosuccinate-synthetase (ASS) deficiency, also called citrullinemia. 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.
Cytonet: the beating heart of the German economy
“Top 100” ranks the most innovative companies in Germany. Cytonet GmbH & Co. KG is among one of them this year.
Weinheim, Germany – Resourceful employees, the courage to take on new challenges, and a creative driving spirit of its research activities have brought the mid-sized company to the top of its sector, landing it a spot on the list of Germany’s top 100 innovators. Lothar Späth is scheduled to present the medical and biotechnology company with the “Top 100” award at a ceremony this Thursday evening in the Warnemünde district of Rostock.
International journalists convene in the BioRN cluster
Cytonet LLC establishes presence in the USA
Cytonet LLC has become established a branch in the important US biotechnology market: In October 2008, Cytonet LLC assumed ownership of a liver cell production facility in Durham, North Carolina.
