Trial Information

Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate

The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into
which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer
cells. The second gene is for human interleukin 2 (IL2) which the body's immune system
makes to help it fight cancer. The TG4010 is given as an injection under the skin
(subcutaneous) once a week for six weeks followed by a schedule of every three weeks or
every three weeks for the first twelve (12) weeks. If the therapy is working, it can be
continued for up to 9 months until no further improvement or until the patient gets worse
for as long as it is tolerated.