European regulators recommend orphan drug status for GPC Biotech's multiple myeloma drug

By E. Janene Geiss

Philadelphia, Feb. 14 - GPC Biotech AG announced Tuesday 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, according to a company news release.

1D09C3 is 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.

The orphan drug program of the EMEA is designed to promote the development of drugs to treat life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union. The designation provides E.U. market exclusivity for up to 10 years in the given indication.

Other potential benefits include a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval and EMEA guidance in preparing a dossier for marketing approval, officials said.

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.

The drug is an anti-MHC (major histocompatibility complex) class II monoclonal antibody and 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 2004, it was estimated that more than 54,000 people in the United States and about 64,000 people in the European Union were newly diagnosed with non-Hodgkin's lymphoma, the most common form of lymphoma.

Multiple myeloma is an aggressive type of non-Hodgkin's lymphoma and affects about 67,000 people in the European Union.

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, officials said.

A phase 1 clinical program evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy, is 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.

GPC Biotech is a Munich, Germany, biopharmaceutical company discovering and developing new anticancer drugs.

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