Soligenix wins US$1.2m development grant
Supports Phase III trial of orBec in acute GI GVHD
Soligenix, a US-based late-stage biopharmaceutical company, has been awarded a three-year US$1.2m clinical research grant by the Office of Orphan Products Development (OOPD) of the US Food and Drug Administration (FDA) as part of its Orphan Products Development (OPD) programme.
The grant will be used to offset some of the costs associated with the firm’s ongoing Phase III clinical trial of orBec in acute gastrointestinal Graft-versus-Host-Disease (GI GVHD). Around 166 patients will be enrolled to this trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec Randomised Treatment Study). The study includes major stem cell transplantation centres in the US, Europe and Australia, and is expected to be completed in the first half of 2011.
‘We believe the award is a validation of the design of our Phase III trial and a clear indicator of the importance of orBec and its potential application in the treatment of acute GI GVHD,’ said Christopher Schaber, president and chief executive of Soligenix. ‘OrBec could become the first FDA-approved therapy to treat and prevent GVHD.’
In addition to issued patents and pending worldwide patent applications, orBec holds orphan drug designations in the US and Europe for the treatment of GI GVHD, as well as an orphan drug designation in the US for the prevention of acute GVHD and the treatment of chronic GI GVHD.