FDA COMMITTEE TO REVIEW DOR'S NDA FOR ORBEC

DOR BioPharma has received notification from the FDA that the Oncology Drug Advisory Committee (ODAC) will review the company's new drug application (NDA) for orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-versus-host disease (GI GVHD) May 9. The company submitted the orBec NDA in November 2006.

"We are very pleased to have this opportunity to present the orBec data in GI GVHD to the ODAC panel, and we look forward to reviewing our application with the FDA advisers," Christopher Schaber, president and CEO of DOR BioPharma, said.

The data provided in the NDA submission demonstrate that orBec may provide a higher rate of survival when compared with the current standard of care and a lowered exposure to systemic corticosteroids following allogeneic transplantation, according to the company. Currently there are no approved products to treat GI GVHD.

The NDA is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first trial was a 129-patient pivotal Phase III multicenter trial conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60-patient Phase II single-center clinical trial. Although orBec did not achieve statistical significance in the primary endpoint of its pivotal trial, namely time to treatment failure through day 50, the drug did achieve statistical significance in other key outcomes such as median time to treatment failure through day 80. It also demonstrated a statistically significant long-term survival advantage compared with placebo, DOR said.