BIOGEN IDEC INITIATES STUDY OF CLL TREATMENT

Biogen Idec has initiated a randomized, controlled registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The Phase II trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), an emerging standard of care, with FCR alone in patients with CLL who have relapsed or failed to respond to initial therapy.

Biogen Idec also announced that lumiliximab was granted fast-track and orphan drug designation by the FDA for the CLL indication. Fast-track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that may fill an unmet medical need, according to the company. Orphan drug designation may qualify a recipient for exclusive marketing rights in the U.S. for seven years if the company is first to receive marketing approval.

The newly initiated randomized registration study, the LUCID trial, will ultimately enroll approximately 276 patients worldwide at more than 90 centers. CD23 is highly expressed on B-CLL cells. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed CLL. The primary study endpoint is complete response rate, a predictor of progression-free survival in CLL patients.

Data from a previous Phase I/II study on lumiliximab was presented in December 2006. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response rate in patients who have CLL that was progressing after prior therapy.