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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

PRINCETON, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Soligenix, Inc. (Soligenix or the Company) (OTC Bulletin Board: SNGX), a late-stage biopharmaceutical company, today reported preliminary results from its Phase 2 "proof-of-concept" exploratory clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period.  The preliminary results indicate that orBec® appears safe and well tolerated in this patient population, but did not achieve statistical significance in the primary endpoint, which was the proportion of subjects who developed acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation.  However, an encouraging result was that use of orBec® resulted in fewer cases of more severe acute GVHD grades IIb-IV (21% vs. 33% of patients receiving placebo), although this difference was not statistically significant.  This result has the potential to be clinically relevant because GVHD grades IIb-IV are associated with more severe disease involving the skin and liver as well as being associated with poorer outcomes, including mortality rates that approach 100% in the grade IV patient population.  Further analysis of the complete dataset continues and is aimed at identifying other potential effects seen with orBec® in preventing acute GVHD.

The Phase 2 prevention study was a randomized, double-blind, placebo-controlled trial that enrolled 140 patients who had been randomized to either orBec® or placebo at a 2:1 ratio.  Prior to HCT, patients began study drug at the start of their conditioning regimen and continued through day 75 following HCT. The study was con
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