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Soligenix Announces Preliminary Results of its Phase 2 Clinical Trial of orBec® in the Prevention of Acute GVHD
Date:10/25/2010

py tailored to treat the GI manifestation of acute 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 GI disorders characterized by severe inflammation.  

In addition to issued patents and pending worldwide patent applications, orBec® benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, as well as an orphan drug designation in the US for the prevention of acute GVHD and the treatment of chronic GI GVHD.  Orphan drug designations provide for 7 and 10 years of market exclusivity upon approval in the US and Europe, respectively.  orBec® has also received Fast Track designation from the FDA for the treatment of GI GVHD.

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
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SOURCE Soligenix, Inc.
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