Intercell's therapeutic Hepatitis C T-cell vaccine (IC41) advances to next Phase II clinical trial

Initial results expected in mid 2007

28-Sep-2006

Intercell AG announced the start of a Phase II - proof of concept - clinical trial for its therapeutic hepatitis C vaccine (IC41). In this Phase II clinical trial, chronic Hepatitis C patients who have not received a previous treatment will be vaccinated with Intercell's therapeutic Hepatitis C vaccine using an optimized route and frequency of administration identified in the optimization study completed earlier this year. Results of this optimization study indicated that IC41, given in optimized route and schedule, is considerably more immunogenic and that the T-cell responses were stronger and significantly more frequent than it has been shown previously.

For the current clinical trial, 50 patients will be enrolled in Germany, Poland and Romania. The study aims to show significant reductions of HCV-RNA through IC41 stand-alone therapy. The vaccination regime used in this Phase II study is expected to achieve significantly stronger T-cell responses than it was observed in previous trials. Previous clinical trials showed that T-cell responses were associated with a clinically meaningful decline of HCVRNA. Initial results of this Phase II study are expected in mid 2007.

Furthermore, Intercell is currently conducting a Phase II clinical trial in 24 patients, testing IC41 in combination with Interferon/Ribavirin standard therapy. Results from this study are expected for end-2006. The primary objectives of this study are safety and the pharmacodynamic interactions of IC41 with standard therapy. Intercell expects the study will further support the potential future development of IC41 in combination therapy settings using the new improved administration scheme of IC41.

https://www.bionity.com/en/news/58285/intercell-s-therapeutic-hepatitis-c-t-cell-vaccine-ic41-advances-to-next-phase-ii-clinical-trial.html