INTERCELL GETS APPROVAL FOR ENCEPHALITIS VACCINE STUDIES

Intercell announced that it has received the approval for the start of Phase III clinical studies for the Japanese Encephalitis Vaccine (IC51) from major European authorities.

The Germany-based Paul Ehrlich Institute has approved the start of respective Phase III clinical trials in Germany, which will contribute the largest contingent for these Phase III studies outside the U.S. The Phase III clinical trials have now been approved in Australia, Austria, Bulgaria, Germany, Romania, the UK and the U.S.

Intercell has aslo received scientific advice from the European Medicines Agency regarding the further development of IC51 in Europe. Based on this advice, the company will proceed with its global development program also with a view to submitting a marketing authorization application in Europe through the centralized procedure.

Having received all necessary regulatory approvals, Intercell plans to start its global, multicenter Phase III trials in September.