Thursday, December 13, 2012

Kyowa Hakko Kirin Initiates Pivotal Phase 3 Trial of Mogamulizumab (KW-0761) in Patients with Cutaneous T-Cell Lymphoma in the United States

Kyowa Hakko Kirin Co., Ltd. has initiated Phase 3 clinical trial in the United States to evaluate the efficacy and safety of mogamulizumab (generic name / code name: KW-0761) in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). Mogamulizumab has been granted orphan-drug designation for the treatment of CTCL by the U.S. Food and Drug Administration and the European Commission.

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including CTCL cells. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC).
Mogamulizumab was approved in Japan in March 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL), and is being investigated world-wide in a number of clinical studies for other potential indications.

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