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news.Biogen Idec's antibody lumiliximab, for patients with chronic lymphocytic leukemia, has been granted fast track and orphan drug designations by the FDA.
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Biogen has also initiated a registartion trial of lumiliximab. Lumiliximab is an anti-CD23 monoclonal antibody. CD23 is highly expressed on B-CLL cells.
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 chronic lymphocytic leukemia (CLL) that has relapsed or failed to respond to initial therapy.
The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed CLL. Complete response rate is the primary study endpoint.
“The development of this antibody is significant because more targeted therapeutic options are needed for CLL patients,” said Ian Flinn, director, Hematologic Malignancies Research, Sarah Cannon Research Institute.