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ARTICLE | Clinical News

OrBec beclomethasone dipropionate: Phase II started

December 9, 2013 8:00 AM UTC

Soligenix began a double-blind, placebo-controlled Phase II trial to evaluate oral orBec for up to 16 weeks in about 40 patients who have received an allogeneic hematopoietic cell transplantation (HCT) >=100 days earlier, have documented chronic GvHD in >=1 organ outside the GI tract and have a mucosal biopsy consistent with GI GvHD. The trial is partially funded by a 2-year, $300,000 Small Business Innovation Research (SBIR) grant from NIH's National Cancer Institute (NCI). orBec has Orphan Drug designation in the U.S. to treat GI symptoms associated with chronic GvHD following allogeneic HCT. The product also has Orphan designation in the U.S. and EU and Fast Track designation in the U.S. to treat gastrointestinal GvHD. ...