Ceplene shows long-term activity in HCV

Maxim Pharmaceuticals has announced positive results in its 72-weekPhase II study evaluating Ceplene (histamine dihydrochloride) plus interferon alfa in treatment-naive, chronically-infected hepatitis C patients (Marketletter April 23) who were randomly assigned to one of four treatment groups.

Each patient received Ceplene in one of four dosing regimens, plus IFN alfa at the standard dose of 3 million international units three times per week for up to 48 weeks of therapy. Patients in the two lower-dose regimens self-administered one dose of Ceplene per day and received either a 3mg or 5mg each week whilst patients in the two higher-dose regimens self-administered two doses of Ceplene per day plus a total of 6mg or 10mg of the drug each week. The primary measure of efficacy was a reduction in viral load and a normalization of liver function.

The study demonstrated that, at 72 weeks, a complete viral response, defined by virus levels being below detection, was sustained in 40% of evaluable patients in all four Ceplene treatment arms combined, and in 44% of patients receiving the highest Ceplene dose of 10mg per week. Patients receiving IFN alfa alone showed only a 16% sustained complete response at 72 weeks. 38% of genotype-1 patients, who have the poorest response to treatment, sustained a complete viral response compared to 8% who were treated with IFN alfa alone.