Digna Biotech and Biotecnol to begin CT-I Phase I trial in healthy volunteers

Digna Biotech and Biotecnol (The Consortium) announced today that the Spanish Regulatory Medicine Agency has authorized the start of a Phase I Clinical Trial in healthy volunteers for Cardiotrophin-I (CT-I). The study will be conducted in Hospital Universitario Puerta de Hierro de Majadahonda in Madrid and Clinica Universidad de Navarra in Pamplona, and will include 33 healthy volunteers.

Researchers from the Center for Applied Medical Research (CIMA) discovered that CT-I is able to stimulate hepatic regeneration after partial hepatectomy, as well as to defend the liver against warm ischemia reperfusion injury. It also protects hepatocytes from death during an acute liver failure situation. Based on these data, CIMA obtained the intellectual property of CT-I for its use in hepatic diseases. The pre-clinical development of CT-I has been possible thanks to the financial support of ClaveSuan, the Center for the Industrial and Technological Development (CDTI) and the Government of Navarra.

The Consortium entered into an Exclusive Option and Licensing agreement with Genentech, Inc (a fully owned subsidiary of the Roche group) in September 2009.

Source: DIGNA BIOTECH