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www.fdanews.com/articles/90964-biogen-idec-initiates-study-of-treatment-for-nhl

BIOGEN IDEC INITIATES STUDY OF TREATMENT FOR NHL

January 26, 2007

Biogen Idec has initiated a Phase III study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The trial will compare treatment with galiximab in combination with Rituxan (rituximab) with Rituxan in combination with placebo in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed or failed to respond to initial therapy.

The TARGET NHL trial is a randomized, double-blind, global, multicenter study. Progression-free survival is the primary study endpoint. An open-label retreatment study with galiximab in combination with rituximab, will be available to subjects who progress on 114-NH-301 after experiencing at least a partial response with a time to progression of six months or greater in either arm of the study.

The study is a registration clinical trial being conducted under a special protocol assessment granted by the FDA. The study will ultimately enroll approximately 700 patients worldwide at more than 150 centers.

Because the CD80 target is found uniformly on Reed-Sternberg cells, the malignant component of Hodgkin's disease, as well as the majority of non-Hodgkin's lymphomas, the company will explore expanded proof-of-concept clinical trials, which will begin in 2007, for other indications.