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Hi-8® MEL

Hi-8 MEL is a therapeutic vaccine for metastatic melanoma. The product uses two different vectors, one based on plasmid DNA and the other based on modified vaccinia virus Ankara, to induce a melanoma-specific cellular immune response. Both vectors contain the Mel3 polyepitope string, which encodes seven defined peptides from five different melanoma-specific antigens.

Clinical proof of concept

The vaccine has been evaluated in 55 patients to date. In a Phase IIa study in 41 patients with non-resectable, stage III/IV melanoma, melanoma-specific cellular responses were seen in 91% of patients receiving the optimal dose of Hi-8 MEL. Eight patients (20%) showed disease control and median survival was significantly improved in immune responders versus non-responders.

Market oportunity

More than 100,000 people are diagnosed with melanoma each year in the seven major pharmaceutical markets. Existing therapies for Stage III/IV metastatic melanoma offer limited efficacy and often have serious side-effects. Worldwide sales of treatments for melanoma are expected to exceed US$775 million in 2010 (source: Datamonitor).