DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointes... (te for the treatment of acute GI GVHD a ...)

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

Date:8/4/2009

te for the treatment of acute GI GVHD, a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants. Similar to acute GVHD, there is also an inflammatory condition of the GI tract associated with cGVHD. Furthermore, acute GI GVHD occurs in approximately 60 percent of related donor and 70 percent of unrelated donor allogeneic transplantation patients and is a risk factor for development of cGVHD.

DOR has previously run two randomized, double-blind, placebo-controlled clinical trials in acute GI GVHD with orBec((R)). The first trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. The second trial was a 129-patient pivotal Phase 3 multi-center clinical trial conducted at 16 leading bone marrow/stem cell transplant centers in the United States and France. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec(R) at 200 days post-transplant with only 5 patient (8%) deaths in the orBec(R) group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the Phase 3 trial, 18 patients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, p=0.04).

Based on data from the prior Phase 3 study of orBec(R), the upcoming confirmatory Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial
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SOURCE DOR BioPharma, Inc.
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DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointes...(te for the treatment of acute GI GVHD a ...)