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news.Biogen Idec has initiated a phase III study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma.
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The trial will compare treatment with galiximab in combination with rituximab
(Genentech/Biogen Idec's Rituxan), to rituximab in combination with placebo in patients with follicular non-Hodgkin's lymphoma (NHL) 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 or refractory, follicular NHL. Progression-free survival is the primary study endpoint.
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.
“The safety profile of galiximab in the early studies, along with its hypothesized novel mechanism with Rituxan, suggests the potential for a new era of combination antibody therapies as treatments for lymphoma,” said David Parkinson, senior vice president, Oncology Research and Development, Biogen Idec.