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KEPIVANCE TRIAL RESULTS PUBLISHED

April 21, 2006

The results of patient evaluations of a Phase III randomized trial of Kepivance (palifermin, epidermal growth factor) for the prevention of oral mucositis in autologous stem cell transplant recipients have been published in the Journal of Clinical Oncology.

In the study, patients receiving Kepivance reported significant improvement in the daily functioning activities of swallowing, drinking, eating, talking and sleeping compared to the control group. This study also documents the effectiveness of Kepivance in preventing oral mucositis in the stem cell transplant setting.

Oral mucositis is a frequent clinical problem in patients receiving chemotherapy and/or radiation therapy. Mucositis can be a severe dose-limiting toxicity, especially in patients receiving autologous or allogeneic stem cell transplants or radiation therapy for head and neck cancers. Patients who have undergone stem cell transplants frequently rate mucositis as the most debilitating side effect of the treatment.