New drug 1D09C3 European orphan status

GPC Biotech AG (NASDAQ: GPCB) today announced that the Committee for Orphan Medicinal Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation for the anticancer monoclonal antibody 1D09C3 for the treatment of multiple myeloma. The orphan drug status becomes effective when the European Commission has approved this recommendation. 1D09C3 is currently in a Phase 1 clinical program 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.

1D09C3 was previously granted orphan medicinal product designation by the European Commission for Hodgkin’s lymphoma and chronic lymphocytic leukemia, a type of non-Hodgkin’s lymphoma.

1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to MHC class II molecules on the cell surface and in preclinical studies appears to selectively kill activated, proliferating tumor cells, which include B-cell and T-cell lymphomas. In preclinical studies, 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 who have failed prior standard therapy, is currently underway at several major cancer centers in Europe. 1D09C3 has been granted orphan medicinal product designation for the treatment of Hodgkin’s lymphoma and chronic lymphocytic leukemia. Additional information on 1D09C3 can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.

This press release may contain projections or estimates about plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements. These statements are forward-looking and are subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company's relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. There can be no guarantee that the Phase 1 trials with 1D09C3 will be successfully completed nor that 1D09C3 will be approved for marketing in a timely manner, if at all. We direct you to the Company's Annual Report on Form 20-F, as amended, for the fiscal year ended December 31, 2004 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the Company's future results, performance and achievements. The Company disclaims any intent or obligation to update these forward-looking statements or the factors that may affect the Company's future results, performance or achievements, even if new information becomes available in the future.

Source: www.gpc-biotech.com