Date: 2011-03-10
Type of information: Initiation of preclinical development
phase: 1
Announcement: authorization delivered by the Spanish Regulatory Medicine Agency
Company: Digna Biotech (Spain) Biotecnol (Portugal)
Product: cardiotrophin-1
Action
mechanism: protein. Cardiotrophin-1 (CT-1) is a member of the interleukin (IL) 6 family of cytokines. The effects of CT-1 are documented in several disease models, such as myocardial infarction and ischemia-reperfusion injury. The receptor of CT-1 is expressed in different organs and tissues (such as the heart, lung and muscle), and the therapeutic efficacy potencial of CT-1 was demonstrated in these organs.CT-1 is expressed in the liver, mainly by parenchimal cells. Binding of CT-1 to its receptor on hepatocyes triggers the activation of cell survival pathways: STAT-3, AKT and ERK1/2. The administration of recombinant CT-1 has shown a clear hepatoprotective effect in several animal models of liver failure, and also has demonstrated its ability to induce liver regeneration in parcial hepatectomy models.
Disease: prevention of delayed graft function
Therapeutic area: Transplantation
Country: Spain
Trial
details: Digna Biotech and Biotecnol announced that the Spanish Regulatory Medicine Agency has authorized the start of a Phase I clinical trial in healthy volunteers for their Cardiotrophin I programme. The study will be conducted in two Spanish hospitals (Hospital Universitario Puerta de Hierro de Majadahonda, in Madrid, and Clínica Universidad de Navarra, in Pamplona). Approximately 33 healthy volunteers will participate in this clinical trial which will run throughout 2011. Researchers from the Center for Applied Medical Research (CIMA) discovered that this protein 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 the death in a situation of acute liver failure. Based on these data, CIMA obtained the intellectual property of CT-1 for its use in hepatic diseases. So far the pre-clinical development of CT-1 has been possible thanks to the financial support from private and public entities, ClaveSuan, the Center for the Industrial and Technological development (CDTI) and the Government of Navarra.
CT-1 has been already granted Orphan Drug Status by European Medicine Agency (EMA), Orphan Designation Number EU/3/06/396) and the FDA for prevention of ischemia/reperfusion injury associated with solid organ transplantation and it is also obtained FDA Orphan Status for liver transplantation.
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