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news.Celsion, an oncology company, has initiated a pivotal Phase I/II study of ThermoDox in combination with hyperthermia, or heat, to treat recurrent chest wall breast cancer, a disease with a very poor patient prognosis and limited treatment options.
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The open-label, dose-escalating pivotal trial has been designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients across the US and to complete the study by the first half of 2010.
Nicholas Borys, Celsion’s vice president and chief medical officer, said: “Recurrent cancer at the chest wall can affect a significant number of breast cancer patients who have had a mastectomy.
“With no current standard of care, women with this type of recurrence often cannot be adequately treated with surgery, radiation, or existing chemotherapy. We believe that the Dignity study will demonstrate that ThermoDox in combination with hyperthermia will provide local tumor control and improve quality of life.”