Phase II Trial in Celiac Disease

In October 2007, we initiated a randomized, double-blind, placebo-controlled, Phase II clinical trial to study Traficet-EN™ in the treatment of patients with celiac disease. We expect to enroll a total of approximately 90 adult volunteer subjects with biopsy-proven celiac disease who have maintained a gluten-free diet for more than two years.

The primary objective of this study is to evaluate the effect of Traficet-EN compared to placebo on the small intestinal mucosal morphology of biopsy specimens taken from subjects with celiac disease on a long-standing gluten-free diet, before and after gluten exposure. Secondary objectives of this study include evaluation of Traficet-EN compared to placebo on small intestinal mucosal inflammation, gluten-induced celiac-type serology, symptom scores, malabsorption parameters and safety and tolerability profiles. If our Phase II clinical trial in celiac disease is successful, we plan to launch further trials to obtain an indication for Traficet-EN in treatment of patients with this disease.

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