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www.fdanews.com/articles/61581-symbollon-to-begin-breast-disease-pain-study

SYMBOLLON TO BEGIN BREAST DISEASE PAIN STUDY

August 9, 2006

Symbollon Pharmaceuticals announced it anticipates closing the enrollment of its IoGen Phase III breast disease pain study by year's end. The ongoing study has more than 25 active sites in the United States. Symbollon is planning to conduct a comprehensive advertising campaign during the remainder of 2006 to assist these sites in recruiting subjects for the study. Symbollon expects to announce the study results in the summer of 2007.

The trial is evaluating the clinical effectiveness of IoGen in women with moderate to severe periodic breast pain associated with fibrocystic breast disease. The company is planning to randomize up to approximately 130 women in the study.

Subjects will receive one 6-mg tablet of IoGen or placebo daily for six months. The primary objective of the study is to evaluate the effectiveness of IoGen by comparing subjects in the treatment and placebo groups that experience a clinically meaningful reduction in breast pain and tenderness.