Biogen reports galiximab in phase 3; lumiliximab scheduled to follow in early 2007

By Jennifer Lanning Drey

Eugene, Ore., Sept. 18 - Biogen Idec, Inc. is advancing two of its antibody therapy compounds, galiximab and lumiliximab, toward registration with the Food and Drug Administration, David Parkinson, senior vice president of research and development at Biogen, said Monday during a presentation at the Leerink Swann & Company cancer roundtable.

Phase 3 registration trials for galiximab have already begun, while registration trials for lumiliximab are scheduled to start in early 2007, he said.

Galiximab, an anti-CD80 agent, is being studied in combination with rituximab in patients with relapsed and refractory non-Hodgkin's lymphoma. The study will involve 700 patients in nearly 20 countries in the United States and Europe.

CD80 expression is present in nearly all follicular non-Hodgkin's lymphomas, all Hodgkin's lymphomas and a majority of patients with diffused large B cell lymphomas, Parkinson said.

"The antigen itself is widely expressed," he said.

In addition to the phase 3 registration trial, Biogen is also studying galiximab as a front-line treatment for patients with follicular non-Hodgkin's lymphoma. The company has completed a 51-patieint phase 2 study and expects to have data in the second half of 2007, Parkinson said.

In addition, Biogen plans to begin a single-arm study next year of galiximab in patients with relapsed Hodgkin's disease. The concept for the study has been approved, and Biogen is preparing a protocol, he said.

Lumiliximab, Biogen's anti-CD23 monoclonal antibody, is also scheduled to begin registrational trials in early 2007. The drug will be studied in patients with chronic lymphocytic leukemia. Other possible indications for the compound include small-cell lymphocytic lymphoma, he said.

The company believes lumiliximab works synergistically with rituximab and fludarabine and will study the compound in combination with both drugs.

Lumiliximab could be accepted for accelerated approval in the United States if data are compelling, Parkinson said.

Cambridge, Mass.-based Biogen develops novel therapies for use in oncology, neurology and immunology.

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