Biogen Idec Initiates Randomized, Registrational Trial of Lumiliximab for Chronic Lymphocytic Leukemia
Novel anti-CD23 antibody granted Fast Track and Orphan Drug designations
Biogen Idec announced that it has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy.
Biogen Idec also announced that lumiliximab was granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) for the above indication. Biogen Idec owns the worldwide rights to lumiliximab.
The newly initiated lumiliximab registration trial enrolled the first randomized U.S. patient January 17, 2007. The patient was treated on January 22, 2007, by Kelly Pendergrass, M.D., at Kansas City Cancer Center in Kansas City, Mo. The first international patient was also treated on January 22, 2007, by Dr. Paul Cannell at Royal Perth Hospital in Perth, Australia. The study will ultimately enroll approximately 276 patients worldwide at more than 90 centers.
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