WEINHEIM, Germany and DURHAM, North Carolina, January 16 /PRNewswire/ -- Cytonet GmbH & Co. KG, Weinheim, and Vesta Therapeutics Inc., Durham (North Carolina, USA), have signed a mutual strategic collaboration agreement. In the context of this collaboration, a GMP facility in accordance with European standards will be constructed on the premises of Vesta Therapeutics, where liver cell products for Cytonet's clinical trials will be produced in the coming years. The first international multi-center studies worldwide should verify the efficacy and clinical suitability of Cytonet's liver cell therapy, helping to promote its authorization in the EU.
Cytonet has managed in recent years to refine techniques of cell isolation and processing to the extent that human liver cells can be obtained in medicinal product quality in a routine production process. This means that the curative treatment of various liver diseases is possible in the sense of genuine "regenerative medicine". Accordingly, vital liver cells from donor organs that cannot be used for transplantation take over essential metabolism and detoxification tasks in the diseased liver. Through the implementation of GMP (Good Manufacturing Practice) for cell isolation, the stringent requirements of German and European drug manufacturing are fulfilled. In addition, the Commercial Regulatory Authority of Lower Saxony, in agreement with the Paul-Ehrlich Institute, have granted Cytonet a manufacturing authorization on this basis, the first time ever for a liver cell product.
With the new types of German production technology, Vesta Therapeutics supplements its own facility know-how.
Vesta Therapeutics Inc., a private company manufacturing cell therapy products, is convinced that this will be a successful collaboration. Mark Johnston, President since 2004, emphasizes the advantages for both sides of this promising partnership: "With Cytonet's technologies, Vesta Therapeutics will become the only producer of European GMP compliant cell-therapeutic liver preparations in the United States. This is an important step on the way to establishing a worldwide, standardized liver cell therapy". "This will be a very productive collaboration, and we are delighted to have entered into this relationship." Additionally, Vesta Therapeutics has an allowed IND from the US FDA for a liver cell therapy and plans to begin trials in the US in the coming year.
"Vesta Therapeutics is a rapidly growing company in the field of cell therapy, with an impressive product and patent portfolio. They are the ideal American partner. With the production of clinical study medication according to European standards, which is now possible there, we are taking a big step together towards the forthcoming approval of liver cell therapy", declares Dr. Dr. Wolfgang Rudinger, one of the two Cytonet directors along with Michael J. Deissner, confirming the excellent prospects for collaboration. The Weinheim biotechnology company was founded in 2000 and today considers itself the market leader in cell therapy in Germany. Cytonet operates cell production and development facilities in Hanover and Heidelberg.
Cytonet GmbH & Co. KG
Cytonet GmbH & Co. KG
CONTACT: Press contact: Michael Tschugg, Cytonet GmbH & Co. KG,Albert-Ludwig-Grimm-Str. 20, D-69469 Weinheim, Phone:+49-(0)-62-01-25-98-19, Fax: +49-(0)-62-01-25-98-28,E-Mail:email@example.com