FDAnews
www.fdanews.com/articles/97461-intercell-hepatitis-c-vaccine-meets-primary-endpoints

Intercell Hepatitis C Vaccine Meets Primary Endpoints

August 21, 2007

Austrian drugmaker Intercell announced the analysis of Phase II interim data for its peptide-based therapeutic vaccine, IC41, in an exploratory clinical study targeting treatment-naïve Hepatitis C patients.

The current study includes 50 patients chronically infected with genotype 1 of the Hepatitis C virus, which is known to be very difficult to treat with interferon/ribavirin standard therapy, according to Intercell.

The patients enrolled in the study have not received any other therapy and were given eight intradermal injections of the IC41 vaccine in biweekly intervals for 14 weeks.

The desired outcome of the ongoing study is the demonstration of a constant and sustained decline in HCV viral load that is increased by reiterative vaccinations during the treatment period.

In the current interim analysis, 25 patients have been evaluated, and the data obtained shows that the primary endpoint set for this study has been met. In the second week after the final vaccination, a 40 percent reduction of viral load was observed in comparison with the baseline prior to vaccination, the company said.

Final results of the study are expected in early 2008.