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www.fdanews.com/articles/73013-emea-recommends-orphan-drug-status-for-gpc-biotech-s-1d09c3

EMEA Recommends Orphan-Drug Status for GPC Biotech's 1D09C3

June 3, 2005

GPC Biotech AG has announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) has recommended the granting of orphan medicinal product designation for the anticancer monoclonal antibody 1D09C3 for the treatment of Hodgkin's lymphoma.

The orphan drug status becomes effective when the European Commission has approved this recommendation. 1D09C3 is currently in a Phase I clinical trial that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, including Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy.