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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

ctive steroid therapy, like orBec®, could have an impact on preventing the development of GVHD very early in the disease process," added Brian L. Hamilton, MD, PhD, Chief Medical Officer of Soligenix.  "The trend towards less severe acute GVHD in the patients treated with orBec® is encouraging. We are continuing to analyze the Phase 2 data for other clinically meaningful signals."

Dr. Hamilton continued, "We obviously remain confident in the ultimate success of our confirmatory Phase 3 study of orBec® in the treatment of acute GI GVHD. This Phase 3 trial is anchored by more than 15 years of clinical research in the treatment setting, including positive results from two prior randomized, double-blind, placebo-controlled studies.  The current Phase 3 study is designed to replicate the endpoint of treatment failure rate at Study Day 80, which was successfully measured as a secondary endpoint (p-value 0.005) in the Company's previous Phase 3 study.  Accordingly, there is no correlation between the prospects for success in these distinctly different therapeutic indications and patient populations.  We continue to make good progress towards completing the confirmatory Phase 3 trial in treatment of acute GI GVHD in the second half of next year."

About orBec®

orBec®, oral beclomethasone dipropionate (oral BDP), is currently the subject of a confirmatory Phase 3 clinical trial in the treatment of acute GI GVHD. This Phase 3 trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec® Randomized Treatment Study), will enroll an estimated 166 patients to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value 0.005) in
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SOURCE Soligenix, Inc.
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