BioWorld International Correspondent

PARIS - IDM Pharma Inc. initiated another Phase II trial of its therapeutic vaccine Uvidem, which it is developing in collaboration with Sanofi-Aventis for the treatment of melanoma.

The trial will involve 50 patients with resected stage II or III melanoma in centers in France, Germany and the UK. The trial will be randomized so that half the patients receive Uvidem alone and half a combination of Uvidem and peginterferon alpha-2b (marketed by Schering-Plough Corp. as ViraferonPeg).

Peginterferon alpha-2b has received regulatory approval in Europe for hepatitis C, and Schering-Plough now is developing it for melanoma.

The company's Uvidem project leader, Didier Landais, explained the reasons for testing Uvidem in conjunction with the drug.

"Peginterferon alpha-2b is a well-known immunomodulator that has been shown in clinical trials to have a positive impact as an immuno-adjuvant in combination with melanoma vaccines," he said. "We anticipate that it may boost the immune response generated by Uvidem, which could translate into more measurable clinical benefits."

Uvidem is composed of mature dendritic cells loaded with lysates from melanoma tumor cell lines. IDM, which now is based in San Diego but retains manufacturing facilities in Paris and Irvine, Calif., explained that the primary objective of the trial is to evaluate the specific immune response triggered by Uvidem, with or without peginterferon alpha-2b.

It is the third Phase II trial IDM has conducted of Uvidem in melanoma. Another is under way in the U.S. in patients suffering from stage III or IV melanoma, while an earlier multicenter Phase II study was carried out in Europe and Australia 2002-03.

IDM has six other products in clinical development, the most advanced of which, Junovan, has completed a Phase III trial in osteosarcoma.

Two compounds are in Phase II trials in bladder cancer and non-small-cell lung cancer, while three are in Phase I in colorectal cancer, hepatitis B and HIV infection.