Intercell's Japanese Encephalitis vaccine safe in Phase III trials

16-Jan-2006

Intercell AG announced the achievement of an important milestone in the progress of its international, multi-center Phase III clinical trial program of its Japanese encephalitis vaccine. An independent Data and Safety Monitoring Board (DSMB), consisting of two European and one US expert from the field of Clinical pharmacology and Vaccinology, has reviewed and evaluated the safety data from the first proportion of subjects vaccinated in the Phase III trial. After discussion of all safety data provided to the board members, the DSMB unanimously concluded that no safety concerns have been observed. From these preliminary results, the safety assessment is favorable which supports the ongoing rapid recruitment of approximately 5,000 subjects in the entire Phase III program.

Completion of recruitment for the pivotal safety and the pivotal immunogenicity trial is expected early this year. Results of these Phase III trials are expected in mid 2006. First license applications will be made in the US, EU and Australia.

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