Date: 2011-09-21
Type of information: Granting of the orphan status in the US
Product name: cardiotrophin-1
Compound: cardiotrophin-1
Therapeutic area: Hepatic diseases - Liver diseases - Rare diseases
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.
Company: Digna Biotech (Spain)
Disease: acute liver failure
Latest news:
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2011-09-21
Orphan status UE: 2011-08-30
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
