Amarillo granted FDA approval for Phase II hepatitis C trial

Accordingly, CytoPharm, the company’s partner in Taiwan, will fund and conduct a clinical trial of 144 chronic hepatitis C patients in Taiwan. The patients will receive one of two different dosages of oral human interferon alpha or placebo. In addition to studies on hepatitis C, CytoPharm will be testing oral interferon in human studies of chronic active hepatitis B and influenza.

The aim of the trial is to reduce relapse rate for those patients who have completed the standard combination therapy, consisting of high dose injectable interferon alpha and Ribavirin given orally. Although most patients respond to the standard therapy, up to 40% of those with certain viral genotypes relapse after treatment. The trial is expected to start in the second quarter of 2008.