FDAnews
www.fdanews.com/articles/68266-gpc-biotech-initiates-trial-with-1d09c3-anticancer-monoclonal-antibody

GPC Biotech Initiates Trial With 1D09C3 Anticancer Monoclonal Antibody

February 2, 2005

GPC Biotech AG has initiated a Phase I human clinical study with its anticancer monoclonal antibody -- 1D09C3.

1D09C3 is GPC Biotech's first internal R&D anticancer program to enter human clinical testing. The study is an open-label, Phase I study that is evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy.

The goal of the study is to determine the safety and tolerance of the antibody in patients and to recommend a dose and schedule for subsequent Phase II studies. The Phase I study program will involve major academic centers in Switzerland, Germany and Italy.