GPC Biotech AG has initiated a phase 1 human clinical study with its anticancer monoclonal antibody-1D09C3. 1D09C3 is GPC Biotech's first internal R&D anticancer programme to enter human clinical testing.

The study is an open label, Phase 1 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 2 studies.

The Phase 1 study programme will involve major academic centres in Switzerland, Germany and Italy. The Swiss site, where the study has now been initiated, is the Oncology Institute of Southern Switzerland (IOSI), a world-renowned oncology centre that has been involved in numerous previous Phase 1 studies.

Marcel Rozencweig, senior VP, Drug Development of GPC Biotech, said: "While good progress has been made in treating non-Hodgkin's lymphoma - the most common form of lymphoma - in recent years, the vast majority of patients eventually relapse. Thus, there remains a major unmet medical need for novel therapies to treat patients who have relapsed or become resistant to other treatments. We are excited about the novel mechanism of action of 1D09C3, which is distinct from the mechanisms of action of the products currently used for the treatment of lymphoid tumours."

1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. The antibody was isolated in collaboration with MorphoSys from its HuCAL library of human antibodies.

In 2004, it was estimated that more than 54,000 people in the US and about 64,000 people in the European Union were diagnosed with non-Hodgkin's lymphoma, the most common form of lymphoma. 1D09C3 has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect.