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news.The Spanish Regulatory Medicine Agency has given approval to Digna Biotech and Biotecnol to commence a Phase I study to evaluate Cardiotrophin-I (CT-I) in 33 healthy volunteers.
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The clinical trial will be conducted in Hospital Universitario Puerta de Hierro de Majadahonda in Madrid and Clinica Universidad de Navarra in Pamplona.
According to researchers at the Center for Applied Medical Research (CIMA), CT-I, a member of the interleukin (IL) 6 family of cytokines, stimulates hepatic regeneration after partial hepatectomy and defends the liver against warm ischemia reperfusion injury.
Based on the findings, CIMA got the intellectual property of CT-I to treat hepatic diseases.
ClaveSuan, the Center for the Industrial and Technological Development (CDTI) and the Government of Navarra have financially supported the pre-clinical development of CT-I.
Digna Biotech and Biotecnol have entered into an exclusive option and licensing agreement with Roche’s fully owned subsidiary Genentech in September 2009.