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Soligenix Announces Completion of Patient Enrollment in Phase 2 Acute GVHD Prevention Clinical Trial
Date:5/12/2010

About GVHD

GVHD is a debilitating and painful disease.  It is a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants.  Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's body – most frequently the gut, liver and skin.  Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea.  If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

Systemic immunosuppressive agents such as prednisone, which are the current standard treatments for GVHD, are associated with high mortality rates due to infection and debility.  Further, these drugs have not been approved for treating GVHD in the U.S. or European Union, but rather are used off-label for this indication.

About orBec®

orBec®, oral beclomethasone dipropionate (oral BDP), represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic.  orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD.  orBec® is formulated for oral administration in GVHD patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.  Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation.  

About Soligenix,
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SOURCE Soligenix, Inc.
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