SCHERING AG RELEASES RESULTS OF TWO CROHN'S DISEASE TRIALS

Schering AG has announced results of two studies of sargramostim for the treatment of Crohn's disease. Results from the Phase III induction trial suggest a treatment benefit but fail to demonstrate superiority in the two primary endpoints of response or remission at eight weeks compared with placebo. However, the Phase II study demonstrated that sargramostim was significantly more effective than placebo for induction of corticosteroid-free clinical remission in steroid-dependent Crohn's disease patients.

The Phase III trial was a multi-center, randomized, double-blind, placebo-controlled study in which 288 patients were randomized in nine countries. Patients received sargramostim or placebo via subcutaneous injection each day for eight weeks. The Phase II trial was conducted in the U.S. and Canada in 129 patients with active corticosteroid-dependent Crohn's disease requiring 10 to 40 mg of prednisone or equivalent. Treatment duration was between 12 to 22 weeks depending on the baseline corticosteroid dose.

Crohn's disease is a chronic gastrointestinal inflammatory disease, diagnosed in more than 1 million patients worldwide, for which there is currently no cure.