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Soligenix Announces Results of Recent Data Safety Monitoring Board Review for Phase 3 orBec® Study in Acute GI GVHD
Date:9/15/2011

PRINCETON, N.J., Sept. 15, 2011 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced that an independent Data Safety Monitoring Board (DSMB) recently completed a pre-specified interim analysis for safety and futility for Soligenix's confirmatory Phase 3 clinical trial of orBec® an oral formulation of beclomethasone dipropionate (BDP) in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

The DSMB recommended that the study be stopped as it is highly unlikely to achieve the predetermined primary objective of efficacy based on the interim results. No safety concerns were raised. As a result of the DSMB's recommendation, patient enrollment in the study will stop and the data will be analyzed.

"We are obviously disappointed with the outcome of the DSMB's review," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Over the coming weeks, we will be analyzing the data.  At this point, we do not know why the primary efficacy endpoint was not demonstrated by orBec®, as two prior studies with very similar designs demonstrated robust efficacy and clinically relevant results in essentially the same patient population. It is not possible at this exact time to determine what explains this unexpected outcome. One of a number of possibilities that will be investigated is that these results may be due to changes in the overall treatment practices of the allogeneic stem cell transplantation patient population that may have had an impact on the treatment effect of orBec® since the previous Phase 3 study was concluded in 2004. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from orBec® therapy, then we will certainly communicate our findings."  

Dr. Schaber continued, "With approximately $7.4 million of cash, we can continu
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SOURCE Soligenix, Inc.
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