Symbollon to step up patient recruitment in phase III pain study

The ongoing IoGen study is being conducted at over 25 active sites across the US. Symbollon is planning to conduct a comprehensive advertising campaign during the remainder of 2006 to assist these sites in recruiting subjects for the study by year-end.

The multi-center phase III pivotal clinical trial is evaluating the clinical effectiveness of IoGen in women with moderate to severe periodic breast pain associated with fibrocystic breast disease (FBD). Currently, there are 25 randomized subjects in the study and an additional 26 subjects enrolled in the screening process. Symbollon is planning to randomize up to approximately 130 women in the study.

Randomized subjects will receive one 6mg 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. Nodularity (lumpiness caused by excess breast tissue) will be evaluated by physicians and used as a secondary efficacy endpoint.

“We are determined to complete the enrollment of this critical study by the end of 2006,” stated Paul Desjourdy, president and CEO of Symbollon. “With our increased financial funding we believe that we finally have adequate resources to complete the patient enrollment in this study. This timetable will allow us to announce the data in the summer of 2007.”