orBec^® GVHD Prevention

Acute GI GVHD is a debilitating and painful disease and represents an unmet medical need. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's (host's) body - most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

orBec^® is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for the prevention of acute GVHD after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens. The trial is being conducted by Paul Martin, MD, at the Fred Hutchinson Cancer Research Center in Seattle, WA and is being supported, in large part, by a National Institutes of Health (NIH) grant. Patients were started on study drug at the start of the conditioning regimen and continue through day 75 following HCT. The primary endpoint is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. The trial has completed enrollment of 140 patients and data is expected to be announced in the second half of 2010.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, orBec^® also benefits from orphan drug designations in the US for the prevention of GI GVHD, which provide for seven years of post-approval market exclusivity.