Multiple sclerosis, one of the most common neurological disorders, affects more than 400,000 people in the United States each year. Despite significant advances in MS therapy, many patients continue to experience disease activity. There is a need for additional MS therapies that offer new approaches to treating the disease.
Daclizumab is a humanized monoclonal antibody that binds to CD25, a high affinity receptor that is expressed at low levels on resting T cells, which are a type of immune cell, and at high levels on T cells that can become activated in response to autoimmune conditions such as MS.
"Daclizumab is believed to work by selectively targeting immune cells that play a key role in MS without depleting healthy immune cells and has the potential to provide a new approach to treating this chronic and debilitating disease," said Gilmore O'Neill, senior director, Experimental Neurology at Biogen Idec. "Daclizumab was well tolerated in the CHOICE trial and significantly reduced MS activity in patients who were not responding to interferon beta."
"We believe the results from the CHOICE study, combined with clinical data from smaller trials of daclizumab in MS, provide a basis for advancing daclizumab into registrational studies as a novel therapeutic for the treatment of patients with relapsing MS," said Mark Rolfe, Ph.D., senior vice president and chief scientific officer of Facet Biotech. "Despite advances in MS treatment, there remains a significant unmet medical need for new therapies such as daclizumab and we look forward to seeing data from our registrational studies."
Results from this Phase 2 study provided evidence for Biogen Idec and Facet Biotech to continue the development of daclizumab in two registrational trials in MS. The Phase 2b SELECT trial is evaluating the efficacy and safety of monthly subcutaneous daclizumab as a monotherapy versus place
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