Thirty-eight patients with malignant melanoma were included in the US study and 53 patients with resected stage II/III melanoma were included in the European study. Sanofi-Aventis has worldwide marketing rights to Uvidem in melanoma.
The trial is designed to assess the safety and clinical activity of Uvidem in patients with stage III or IV melanoma with measurable lesions.
The primary objective of the European trial is the evaluation of a specific immune response against tumor antigens following treatment with Uvidem, administered with or without peginterferon alpha-2b in patients with resected stage II or III melanoma. Secondary objectives are safety and disease free survival.
“We anticipate that we will be able to complete the analysis of these trials and provide initial results during 2007,” said Bonnie Mills, VP, Clinical Operations and General Manager US Operations for IDM.