Enteron Pharmaceuticals, Inc.

Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.