Patients in the Phase III trials who have been receiving the 1,200-mcg dose will now receive a 900-mcg dose. The change is based on recommendations made by the studies’s independent Data Monitoring Committee (DMC). Human Genome Sciences (HGS) expects to have all Phase III data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009.
Thomas Watkins, president and CEO of HGS, said: “The 900-mcg dose demonstrated comparable efficacy and safety to Pegasys in Phase II -with half the injections, improvements in quality of life and fewer missed days of work during treatment. We believe that Albuferon could become the market-leading interferon for the treatment of hepatitis C if Phase II 900-mcg results are confirmed in Phase III.”