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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

ducted primarily at the Fred Hutchinson Cancer Research Center in Seattle, WA and was supported, in large part, by a National Institutes of Health (NIH) grant.  The impetus for this NIH-funded prevention study came from two double-blind, randomized, placebo-controlled trials showing that orBec® was effective and safe as a treatment for acute gastrointestinal (GI) GVHD.  

Paul J. Martin, MD, Principal Investigator for the Phase 2 study and a Member, Fred Hutchinson Cancer Research Center stated, "Trials with orBec® have shown a consistent and positive clinical response in the treatment of acute GI GVHD.  We therefore designed a trial to determine whether orBec® could be used to prevent GVHD. Preliminary analysis indicates that administration of orBec®  starting before transplantation did not provide a statistically significant clinical advantage in preventing acute GVHD in this study, possibly because of confounding factors associated with the chemotherapy or radiation.  Preventive administration of orBec® to reduce the incidence or severity of GVHD warrants further investigation, for example, by starting orBec® dosing after transplantation, closer to the initial inflammatory insult of acute GVHD.  We are continuing to analyze the data in order to gain a better understanding of potential preventive treatment effects in this patient population and to determine the best approach for subsequent study."   

Dr. Martin continued, "In my mind, the results from this prevention study have no clinical implication regarding the likelihood of success in the ongoing Phase 3 study of orBec® for the treatment of acute GI GVHD."

"This Phase 2 clinical trial was truly proof-of-concept and the first of its kind. It was an aggressive approach to determining if a topically-a
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SOURCE Soligenix, Inc.
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