Maxim's Ceplene to enter major HCV trial

Maxim Pharmaceuticals' lead drug Ceplene (histamine dihydrochloride) hasbeen selected for inclusion in a major new study seeking to develop new treatment strategies for chronic hepatitis C virus infection that can "increase the sustained viral response to therapy, while minimizing impairment of quality of life and socio-economic burden," according to the firm.

The Dynamically Individualized Treatment of Hepatitis C Infection and Correlates of Viral/Host Dynamics (DITTO-HCV) study is being sponsored by the European Commission and Roche, amongst others, and will enrol up to 300 patients. Several regimens will be evaluated, including a triple-drug combination of Ceplene with peginterferon alfa and ribavirin.

The news is a fillip for Maxim, which received a non-approvable letter from the US Food and Drug Administration for Ceplene as an adjuvant to interleukin-2 for the treatment of patients with advanced metastatic melanoma with liver metastases earlier this year (Marketletter January 29). 72-week results from a Phase II trial of Ceplene and interferon alfa in HCV are due to be presented on April 20, after this issue of the Marketletter goes to press.