Carfilzomib is a late-stage, selective next-generation proteasome inhibitor with a mechanism of action aimed at increasing therapeutic efficacy and limiting the side effects associated with currently available therapies. Carfilzomib is being developed as a treatment for multiple myeloma; we are also exploring its safety and activity in selected solid tumors.  To date, the agent has generated a positive efficacy signal in multiple clinical studies with an encouraging safety profile, including low rates of neuropathy.

A 266-patient Phase 2b trial in patients with relapsed and refractory multiple myeloma, known as the 003-A1 trial, generated positive  data in a highly refractory and heavily pre-treated group of patients with multiple myeloma.  These data will be used to support a potential new drug application (NDA) filing, which is expected to be submitted as early as mid- 2011.  In January 2011, the U.S. Food and Drug Administration (FDA) granted fast track designation for carfilzomib.

Carfilzomib is currently being evaluated in two Phase 3 clinical trials.  The first is a Phase 3 international randomized trial, known as the ASPIRE trial, evaluating the safety and efficacy of carfilzomib in combination with lenalidomide and low-dose dexamethasone versus lenalidomide and low-dose dexamethasone alone, as a potential treatment for patients with relapsed multiple myeloma.  The second, known as the FOCUS trial, is a Phase 3 study of single-agent carfilzomib in the relapsed and refractory setting and is designed to support a regulatory filing in Europe. In addition to the ongoing clinical studies in patients with multiple myeloma, carfilzomib is also being evaluated in a Phase 1b/2 study in patients with advanced solid tumors.

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