IDM Pharma has initiated a Phase II clinical trial in Europe of its therapeutic vaccine Uvidem, under development in collaboration with sanofi-aventis, for the treatment of melanoma.
The trial will recruit 50 patients with resected Stage II or III melanoma who will be randomized to receive either Uvidem alone or Uvidem combined with peginterferon alpha-2b. Peginterferon alpha-2b has been approved in Europe for the treatment of hepatitis C, and is currently under development by Schering-Plough for the treatment of melanoma.
The primary objective of this trial is the evaluation of a specific immune response to the vaccine after treatment with Uvidem, with or without peginterferon alpha-2b. The secondary objectives are safety and disease-free survival. The trial will be conducted in centers in France, Germany and the UK.