DOR BioPharma to Study Treatment to Prevent GVHD

DOR BioPharma has received clearance from the FDA to conduct a Phase II clinical trial of orBec for the prevention of graft-versus-host disease (GVHD).

The trial is supported in part by an NIH grant awarded to the Fred Hutchinson Cancer Research Center and will be reviewed by the center's institutional review board. The study is a randomized, double-blinded, placebo-controlled trial that will enroll a total of 138 patients, with 92 subjects in the orBec arm and 46 subjects in the placebo arm. Patients will be treated with orBec or placebo at the start of their conditioning regimens and will continue to be treated for 75 days after transplant.

The objectives of the trial are to test the hypotheses that prophylactic administration of orBec can prevent the incidence and reduce the severity of acute GVHD, therefore decreasing the need for use of high-dose systemic steroid treatment after allogeneic hematopoietic stem cell transplantation. The trial is expected to begin enrolling patients in the second quarter of 2007.

"Given the positive outcomes of orBec for the treatment of gastrointestinal GVHD, we believe we will be able to demonstrate that orBec, when administered as a preventative therapy, will have a meaningful impact on acute GVHD," Christopher Schaber, president and CEO of the company, said.

The company has filed applications for orBec for treating gastrointestinal GVHD with the FDA and the European Medicines Agency.