DOR BIOPHARMA ANNOUNCES TOP-LINE RESULTS OF PHASE III TRIAL OF ORBEC FOR INTESTINAL GRAFT-VERSUS-HOST DISEASE

DOR BioPharma has announced the top-line results of its multicenter, pivotal Phase III clinical trial of orBec (oral beclomethasone dipropionate) for the treatment of intestinal Graft-versus-Host Disease (iGVHD).

One hundred and twenty-nine post-bone-marrow transplant patients presenting with Grade II iGVHD were enrolled in the randomized, double-blind, placebo-controlled, multicenter clinical trial, which was conducted at 16 bone marrow transplant centers in the U.S. and France.

All patients in the Phase III clinical trial were initially treated with constant daily high-dose (1-2 mg/kg) prednisone, which is the current standard therapy, in combination with an oral dose of either orBec (8 mg/day) or placebo for the first 10 days. On Day 10, if patients were responding to treatment, the high-dose prednisone was rapidly tapered and patients continued to receive either orBec or placebo orally for an additional forty days.

The primary endpoint of the study was a comparison between the two treatment arms of the time to treatment failure, defined as the need for additional therapies due to uncontrolled signs or symptoms of GVHD. Secondary endpoints in the study included a comparison of the proportion of treatment failures and clinical scores at 10 days, 30 days, 50 days, 60 days and 80 days post-randomization, a comparison of cumulative exposure to systemic steroids, as well as a comparison of mortality at Day 200 post-transplant.

iGVHD is a life threatening condition that is one of the most common causes for the failure of bone marrow transplant procedures. orBec represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic.