La Agencia Europea del Medicamento aprueba como medicamento huérfano otra patente del CIMA de la Universidad de Navarra
The European Agency for the Evaluation of Medicinal Products has given "orphan drug" status to another patent from the CIMA
The protein CT-1 may be able to increase the number of livers which are in transplantable conditions, and reduce damage to the organ
The European Agency for the Evaluation of Medicinal Products has designed Cardiotrophin-1 (CT-1) as an orphan drug. This protein is among the patents obtained by the Center for Applied Medical Research (CIMA) of the University of Navarra. The development rights for this protein belong to Digna Biotech, which develops the intellectual property of the CIMA during the preclinical, clinical and commercial stages. CT-1 will be used in the transplant of organs.
The approval, which was granted after a favorable opinion was obtained from the Committee for Orphan Medicinal Products (COMP), provides a number of advantages for the clinical development which will be undertaken by Digna Biotech: free access to the scientific assessment of the European Agency for the Evaluation of Medicinal Products for the design of the clinical phase, a reduction in the costs of the commercial authorization of the product, and 10 years of exclusivity in the market.
CT-1 has a potent stimulant effect on liver regeneration, and acts as a protector in situations of acute damage to the liver, in particular that which is produced by ischemia and reperfusion. It will therefore aid in increasing the percentage of livers which are in transplantable conditions, where currently 22% arrive in poor conditions and cannot be transplanted. In addition, this protein should reduce the damage suffered by the organ during the operation, which currently causes failure in some 15% of transplants. In Spain, approximately 1,000 operations of this type are performed each year, and 12,000 worldwide, which a cost of approximately 50,000 € each.
It is also believed that the protective and regenerative effect of CT-1 should be useful in the treatment of other diseases, such as fulminating hepatitis, and in major resections (partial or total removal of the liver).
The protein has already shown its effectiveness at the preclinical stage, and preparations are being made for the clinical stage of product development. It is estimated that CT-1 should complete its development in 2011.
Digna Biotech is a biotechnology headquartered in Navarra, created through an agreement between the University of Navarra and a group of investors that represent some of the most important corporations in Spain.