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Trial Shows Positive Results for Hodgkin Lymphoma Drug

Seattle Genetics Inc., a biotech company in Bothell, Washington, and and Millennium, a developer of cancer drugs in Cambridge, Massachusetts, today released positive top-line results from a trial of their drug brentuximab vedotin. The drug is antibody-drug conjugate that works like an antibody carrying molecules toxic to cancer cells, targeted to CD30, a marker for neoplastic cells of Hodgkin’s lymphoma (HL).

The trial was conducted with 102 relapsed or refractory (treatment resistant) HL patients. Some 75 percent of patients in the trial achieved the desired response from the drug as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The companies say the safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience.

The clinical trial, say the companies, was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA) and was discussed with the European Medicines Agency (EMA) during the process of obtaining EU Centralized Scientific Advice on the brentuximab vedotin development program. Brentuximab vedotin has been granted orphan drug designation by the FDA and EMA, and granted fast track designation by the FDA for HL.

Hodgkin lymphoma, also called Hodgkin disease is a cancer of the immune system that is marked by the presence of a type of cell called the Reed-Sternberg cell. The National Cancer Institute says there have been about 8,500 new cases and 1,320 deaths from the disease in 2010.

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