The Spanish Agency of Medicines and Health Products (AEMPS) has authorized business biotech Digna Biotech to start the research clinical phase with interferon alfa-5. This patent from research center Médica Aplicada (CIMA ) of the University of Navarra is indicated for patients with "chronic hepatitis C genotype 1" who have not been cured by previous treatment.

After successfully completing the preclinical programs of study , Digna Biotech will launch trials in the coming weeks to evaluate the safety and efficacy of this molecule in 75 patients. Initially, 5 Spanish hospitals will participate; among them, the Clínica Universidad de Navarraas the center of reference letter. It is estimated that the clinical development of interferon alfa-5, if successfully completed, could reach patients in 2015.

170 million people with hepatitis C, more than half of which are genotype 1 patients

Interferon alpha is a protein group that is naturally produced in our body as a defense against the presence of viruses and cancer cells. In this line, different subtypes have been identified, such as interferon alpha-5, which has the advantage of being produced mainly in the liver of healthy people. In the comparative programs of study it seems to activate antiviral genes more effectively. These data should be confirmed in controlled clinical trials to be initiated by Digna Biotech.

Hepatitis C is a disease caused by infection with a virus that causes the liver to become inflamed and stop functioning properly. Only 20% of these infections heal spontaneously, and the rest become chronic and cause an inflammatory disease that progresses to liver fibrosis, cirrhosis and even cancer.

Conventional treatment (combination of interferon alpha-2 and ribavirin) of hepatitis C genotypes 2 and 3 is effective in 80% of patients. But it drops to 50% in cases with genotype 1, the most common genotype in the Western world. "The efficacy of interferon alpha-5 is similar to that of interferon alpha-2 in cell culture viral infection. But, in addition, the joint administration of interferon alpha-5 and interferon alpha-2 improves the response of the antiviral genes with respect to the administration of interferon alpha-2 or alpha-5 separately, so the treatment of hepatitis C with interferon could be improved if these results are confirmed at the clinical level," explains Iranzu González de la Tajada, Ph.D. in Biology, manager of project of Digna Biotech.

According to Dr. Pablo Ortiz, director general manager of Digna Biotech, "our goal is that interferon alpha-5 will contribute in the future to a better treatment of hepatitis C patients. After five years of work and 8 million euros of investment, we have successfully completed the preclinical programs of study . During the next two years we will need another 6 million euros for fill in Phase II. It is estimated that by 2015 interferon alfa-5 will have a potential market of €5 billion." The development of this CIMA has been made possible thanks to the financial support of the Government of Navarra and the Center for Industrial Technological development (CDTI), part of the Ministry of Science and Innovation.

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