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news.DOR BioPharma has commenced patient enrollment for its Phase II clinical trial of orBec, for the prevention of acute graft-versus-host disease (GVHD), a common serious complication of bone marrow transplantation for cancer.
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Up to 138 (92 orBec and 46 placebo) patients will be enrolled. The primary endpoint of the 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.
Patients in the orBec group will begin study drug at the start of the conditioning regimen and continue through day 75 following HCT. Trial enrollment is expected to complete in the second quarter of 2008.
DOR has filed an new drug application with the FDA for the treatment of gastrointestinal (GI) GVHD, and has received a PDUFA date of July 21, 2007. An MAA with the EMEA for orBec has also been filed and validated. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation.
“This orBec prophylaxis study initiates the next stage of our pipeline development where we intend to expand the scope of our portfolio in the areas of treating and preventing life-threatening side effects of cancer treatments and serious gastrointestinal diseases,” said Christopher Schaber, president and CEO.