FDAnews
www.fdanews.com/articles/74841-enrollment-begins-in-hepatitis-c-clinical-trial

ENROLLMENT BEGINS IN HEPATITIS C CLINICAL TRIAL

July 29, 2005

Transition Therapeutics announced that patient enrollment has commenced for a Phase I/II clinical trial of its Interferon Enhancing Therapy, HCV-I.E.T. in hepatitis C patients. The goal of this trial is to evaluate the efficacy of HCV-I.E.T. in the 45 percent of hepatitis C patients that do not respond to standard interferon and ribavirin combination therapy and have no treatment options available.

The trial will enroll 28 hepatitis C patients who have not responded to pegylated interferon and ribavirin. The participants will receive twice-weekly treatments of EMZ702 administered along with standard pegylated interferon and ribavirin. The primary efficacy endpoint will be the reduction of HCV RNA viral load, a clinical endpoint indicative of positive response to therapy.

HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with the current standard of care for hepatitis C, a combination therapy of pegylated interferon alpha and ribavirin.