Elan and Biogen Idec Initiate First Clinical Trial of TYSABRI in Oncology
Elan Corporation, plc and Biogen Idec announced the initiation of the first clinical trial of TYSABRI® (natalizumab) in oncology. The first dose of TYSABRI was administered 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. TYSABRI is a recombinant, humanized monoclonal antibody that targets the adhesion molecule VLA4 (also known as alpha-4 integrin) 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.
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 6 months. After 6 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.
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