Biogen Initiates Randomized Trial of Lumiliximab for Advanced CLL

CAMBRIDGE, Massachusetts—Biogen Idec has initiated a randomized, multicenter, registration trial, known as LUCID, of its anti-CD23 monoclonal antibody lumiliximab in combination with fludarabine, cyclophosphamide, and rituximab (FCR) vs FCR alone for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The antibody was also granted Fast Track and Orphan Drug designation by FDA. In a phase I/II trial reported at the 2006 ASH Annual Meeting, the addition of lumiliximab to the FCR regimen resulted in a 52% complete response rate among CLL patients with progressive disease, the company said.