June 6, 2006

Oxxon Therapeutics has reported data from its Phase II clinical study of its novel Hi-8 MEL therapeutic vaccine in patients with advanced non-resectable melanoma.

The Phase II dose-escalation study has met its clinical endpoints, demonstrating that immunisation with Hi-8 MEL therapeutic vaccine is well tolerated at all doses and shows clinical benefit in HLA-A2 positive patients.

The study found that patients receiving any dose of Hi-8 MEL who developed a CD8+ response specific to Melan-A (one of seven melanoma-specific epitopes used in the Hi-8( MEL treatment) in the first 16 weeks had a median survival of 86 weeks compared to 37 weeks for immunological non-responders. For control purposes a cohort of comparable patients that were HLA-A2 negative and received standard care were followed and had a median survival of 42 weeks.