GPC Biotech Announces Clearance to Initiate Additional Phase 1 Clinical Trial with 1D09C3 Anticancer Monoclonal Antibody

10-Nov-2005

GPC Biotech AG announced that it had received clearance from the Paul-Ehrlich-Institut (PEI) to initiate human clinical testing in Germany with the 1D09C3 anticancer monoclonal antibody. The PEI is the German national agency responsible for regulating biological and blood products.

The study is an open label, Phase 1 trial evaluating 1D09C3 in patients with relapsed or refractory B-cell tumors who have failed prior standard therapy, and is using a different dosing regimen from the Phase 1 study currently underway in Switzerland and Italy. The goal of the trial is to determine the safety and tolerability of the antibody in patients and to recommend a dose and schedule for subsequent Phase 2 studies. This second Phase 1 study is being conducted at the University Hospital of Cologne under the direction of Prof. Michael Hallek, M.D., Director of the Department of Internal Medicine.

1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to MHC class II molecules on the cell surface and selectively kills activated, proliferating tumor cells, which include B-cell and T-cell lymphomas. In 2004, it was estimated that more than 54,000 people in the U.S. 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. A Phase 1 clinical program evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas, such as Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy is currently underway at major cancer centers in Europe. GPC Biotech has been granted orphan medicinal product designation for the treatment of Hodgkin's lymphoma by the European Medicines Agency (EMEA).

https://www.bionity.com/en/news/50141/gpc-biotech-announces-clearance-to-initiate-additional-phase-1-clinical-trial-with-1d09c3-anticancer-monoclonal-antibody.html