Seattle Genetics Inc announced that the US FDA has granted orphan drug designation to its product candidate SGN-40 for multiple myeloma. SGN-40 is a humanized monoclonal antibody that Seattle Genetics is currently evaluating in a phase I clinical trial for the treatment of multiple myeloma. The company plans to initiate another phase I study of SGN-40 for the treatment of non-Hodgkin's lymphoma later this year.
"We are advancing our phase I clinical trial of SGN-40 in multiple myeloma and plan to report preliminary data at the American Society of Haematology annual meeting in December," Clay B Siegall, president and chief executive officer of Seattle Genetics commented adding, "This orphan drug designation is an important component of our SGN-40 development strategy and provides us with a number of potential financial and marketing benefits."
Orphan drug designation, granted by the FDA's Office of Orphan Products Development, provides Seattle Genetics with the opportunity to obtain grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses, potential waiver of the FDA's application user fee and seven years of marketing exclusivity in the event of market approval. Seattle Genetics previously received orphan drug designations for its SGN-30 product candidate in both Hodgkin's disease and T-cell lymphomas.
Myeloma is a cancer of plasma cells, a type of white blood cell found primarily in the bone marrow. In myeloma, a plasma cell becomes malignant, growing continuously, destroying normal bone tissue and crowding out normal blood cell production. Multiple myeloma is an incurable disease in which patients can experience symptoms that significantly impact their quality of life, including pain, anaemia, fatigue, recurrent infection and kidney failure.