DOR BioPharma Announces FDA Clearance of IND for DOR201 in Radiation Enteritis

Ewing, NJ – December 8, 2008 – DOR BioPharma, Inc. (OTCBB: DORB) (“DOR” or the “Company”), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that the U.S. Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis. DOR is, therefore, cleared to initiate a Phase 1/2 clinical trial in acute radiation enteritis.

The IND application included the Phase 1/2 protocol BDP-ENT-01, which is designed as a multicenter, open-label, sequential, dose-escalation study in approximately 36 patients. Patients with rectal cancer who are scheduled to undergo concurrent radiation and chemotherapy prior to surgery will be enrolled in four dose groups. The objectives of the study are to evaluate the safety and maximal tolerated dose of escalating doses of DOR201, as well as the preliminary efficacy of DOR201 for prevention of signs and symptoms of acute radiation enteritis. The study is planned to be initiated in the first half of 2009.

source: DOR BioPharma