Drug Development
IoGen-phase III clinical trial for fibrocystic breast disease begins
Published in Biotech Business Week, July 11th, 2005
Bioaccelerate Holdings, Inc., (BACLE) and Symbollon Pharmaceuticals, Inc., (SYMBA) announced the initiation of patient enrollment in the first multicenter phase III pivotal clinical trial of IoGen, an oral dosage form of Symbollon's proprietary iodine technology, in patients with moderate to severe periodic breast pain associated with symptomatic fibrocystic breast disease (FBD).
The randomized, double-blind, placebo-controlled, single-dose study will evaluate the clinical effects of IoGen in about 175 women.
Patients will receive one 6.0 mg tablet of IoGen or placebo daily for 6 months. The primary objective of the study is the evaluation of...
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