September 5, 2008
Elan and Biogen Initiate First Phase I/II Myeloma Trial
Elan and Biogen Idec have initiated the first clinical trial of Tysabri in oncology. The first dose of Tysabri was administered earlier in the trial. The objectives of this Phase I/II study are to evaluate the safety and potential anti-tumor activity of Tysabri in patients with relapsed or refractory multiple myeloma.
This Phase I/II, open-label, two-arm study is designed to evaluate the safety and anti-tumor activity of Tysabri in patients with relapsed or refractory multiple myeloma. In the Phase I portion of the trial, a standard dose-escalation design will be used to assess the safety and tolerability of Tysabri in up to 12 patients. In the Phase II portion of the study, up to 30 patients will be randomized to the tolerated doses identified in Phase I of the study.Treatment cycles will consist of intravenous infusions of Tysabri once every 28 days for six months. After six months, if the patient has achieved a partial or a complete response, he or she may continue to receive Tysabri once every 28 days until progression of disease occurs.
Patients eligible for the study must be at least 18 years of age with relapsed or refractory multiple myeloma who have failed or cannot tolerate therapy with bortezomib and thalidomide or lenalidomide.
Tysabri is a recombinant, humanized monoclonal antibody that targets the adhesion molecule VLA4 that is expressed on the surface of many types of immune cells. VLA4 is also found on the surface of multiple myeloma cells and may be involved in their survival.
Gordon Francis, senior vice president of global clinical development at Elan, said: "This clinical trial in oncology represents an opportunity for Tysabri to continue to address unmet medical needs, potentially bringing new therapeutic options to patients and their oncologists."