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news.Soligenix, a late-stage biopharmaceutical company, has completed patient enrollment in a randomised, double-blind, placebo-controlled Phase 2 clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens.
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The Phase 2 trial enrolled 140 patients who have been randomised to either orBec or placebo at a 2:1 ratio. The primary endpoint of this trial is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation.
Subjects in the orBec group began study drug at the start of their conditioning regimen and continued through day 75 following HCT. Results from the Phase 2 study are expected in the second half of 2010.
Christopher Schaber, president and CEOof Soligenix, said: “We are pleased to announce the important milestone of enrollment completion in this study aimed at preventing the potential morbidity associated with acute GVHD which is an unmet medical need.
“We appreciate the efforts of the clinicians involved with the study led by Paul Martin at the Fred Hutchinson Cancer Research Center, as well as the participation from the patients. We are looking forward with great anticipation to announcing the results of this study.”