The European Medicines Agency has designated Cardiotrophin-1 (CT-1), one of the patents of research center Médica Aplicada (CIMA) of the University of Navarra, as an orphan drug. This protein from Digna Biotech, business which is developing at the preclinical, clinical and commercial levels the intellectual property (patents) of CIMA, will be used in organ transplantation.

The approval, following the favorable opinion of the committee of Orphan Medicinal Products (COMP), will entail a series of advantages for the clinical development that Digna Biotech will carry out: free access to the scientific advice of the European Medicines Agency for the design of the clinical phase, reduction of the fees for the commercial authorization of the product and exclusivity of 10 years in the market.

CT-1 has a potent stimulatory effect on liver regeneration and acts as a protector in situations of acute liver damage, especially that produced by ischemia and reperfusion. In this way, it could increase the percentage of livers in condition to be transplanted, since at present 22% arrive in poor condition and cannot be used. Likewise, this protein could reduce the damage suffered by the organ during the operation, which causes the failure of 15% of liver transplants. About 1,000 surgeries of this type are performed annually in Spain subject and 12,000 worldwide, at an approximate cost of 50,000 € each.

The CT-1 could fill in its development in 2011.

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

For the time being, its effect has been demonstrated at the preclinical level and the necessary programs of study is being carried out to initiate the clinical phase of the product. It is estimated that CT-1 could fill in its development in 2011.

Digna Biotech is a Navarran biotech company created from the agreement of partnership reached between the University of Navarra and group of investors representing some of the most important companies in Spain.

This patent is the result of the work carried out at CIMA, which with its 370 researchers and technicians researches in the areas of Gene Therapy and Hepatology, Neurosciences, Oncology and Cardiovascular Sciences, and takes advantage of the existing synergies with the University Clinic and the Schools of Sciences, Pharmacy and Medicine of the University of Navarra to obtain results that can be applied to patients.