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Home » ENROLLMENT OF PHASE I/II HEPATITIS C CLINICAL TRIAL BEGINS
ENROLLMENT OF PHASE I/II HEPATITIS C CLINICAL TRIAL BEGINS
August 2, 2005
Transition Therapeutics Inc. has 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.
In the Phase I/II clinical trial, 28 hepatitis C patients who have not responded to pegylated interferon and ribavirin, 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.
EMZ702 has an excellent safety profile and the combination of EMZ702 with interferon and ribavirin in surrogate models for hepatitis C has demonstrated a two to three fold increase in anti-viral potency compared to interferon and ribavirin alone. The strong anti-viral response observed in surrogate models has enabled the rapid advancement of HCV-I.E.T. into clinical development with hepatitis C patients.
KEYWORDS Drug Pipeline Alert
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