July 2006

A protein for organ transplants.

The European Agency for the Evaluation of Medicinal Products has just classified a patent from the Centre of Applied Medical Research (CIMA) of the Universidad de Navarra as an "orphan drug". The drug is Cardiotrofina-1 (CT-1), a protein that will be used in organ transplants by Digna Biotech, a company that develops the intellectual property of CIMA in the pre-clinical, clinical and commercial trial phases.

An "orphan" drug is one that shows potential in the treatment of rare or complex pathologies. According to the Universidad de Navarra, this approval, following the favourable verdict of the Committee for Orphan Drug Products (COMP), will represent a number of advantages for the clinical development to be carried out by Digna Biotech: free consultancy from the European Agency for the Evaluation of Medicinal Products (EMEA) in the design of the clinical phase, lower charges for the commercial authorisation of the product and 10 years exclusivity in the market.

CT-1 has a strong regenerative effect on the liver and acts as a protector in cases of acute damage to this organ, particularly that caused by ischemia and reperfusion.

This could increase the percentage of livers that can be transplanted; at present 22% arrive in poor condition and cannot be used.

This protein could also reduce the damage caused to the organ during the operation, which causes 15% of liver transplant failures. In Spain around 1,000 operations of this type are carried out every year and 12,000 worldwide, at an approximate cost of 50,000 euros a time.

Furthermore, it is believed that the protective and regenerative effect of CT-1 could be useful for the treatment of other illnesses such as fulminant hepatitis and in large resections (total or partial excisions).

So far, its effect has been demonstrated in a pre-clinical trial and studies are now being carried out in order to start the clinical phase. It is estimated that the development of CT-1 could be completed in 2011.

Digna Biotech is a Navarre-based biotechnology company that emerged from a collaboration agreement between the Universidad de Navarra and a group of companies, among them Sodena, Caja Navarra and Caja Rural de Navarra.

370 researchers and technicians work in CIMA.

Journal of the American College of Cardiology