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news.Biopharmaceutical company 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 skin cancer.
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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, marketed as ViraferonPeg by Schering-Plough.
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. IDM has obtained approval for the study from British and French health authorities and has requested approval from the German health authority.
“Peginterferon alpha-2b is a well known immuno-modulator that has been shown in clinical trials by others to have a positive impact as an immuno adjuvant in combination with melanoma vaccines,” Dr Didier Landais, Uvidem project leader at IDM. “We anticipate that it may boost the immune response generated by Uvidem which could translate to more measurable clinical benefits for the patients enrolled in our clinical trials.”
A separate phase II trial of Uvidem is ongoing in the US in patients with stage III or IV melanoma. IDM recently began the second stage of that trial based on positive clinical results in the first stage.