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Published on 11/9/2005 in the Prospect News Biotech Daily.

GPC Biotech gets OK to begin human testing of anti-cancer antibody 1D09C3

By E. Janene Geiss

Philadelphia, Nov. 9 - GPC Biotech AG announced Wednesday that it has received clearance from the Paul-Ehrlich-Institute to start human clinical testing in Germany of the 1D09C3 anti-cancer monoclonal antibody.

The Paul-Ehrlich-Institute 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 standard therapy, and is using a different dosing regimen from the phase 1 study currently underway in Switzerland and Italy, officials said in a company news release.

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, officials said.

This second phase 1 study is being conducted at the University Hospital of Cologne under the direction of Michael Hallek, director of the department of Internal Medicine.

"We are fortunate to have the opportunity to work with professor Hallek. He is a world-renowned expert in the treatment of hematological malignancies and has worked with GPC Biotech for several years on the development of 1D09C3," Marcel Rozencweig, senior vice president of drug development at GPC Biotech, said in the release.

ID09C3 is an anti-MHC class II monoclonal antibody that binds to MHC class II molecules on the cell surface and selectively kills activated, proliferating tumor cells, which include B-cell and T-cell lymphoma.

GPC is a Munich, Germany, biotechnology company focused on the discovery of anti-cancer drugs.


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