DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) ...( PRINCETON N.J. June 9 /- DOR BioPharm...),Health

PRINCETON, N.J., June 9 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (DOR or the Company) (OTC Bulletin Board: DORB), a late-stage biopharmaceutical company, announced today that it has received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of its confirmatory, pivotal, Phase 3 clinical trial evaluating its lead product orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD).

The EMEA agreed that should the new confirmatory Phase 3 study produce positive results, the data would be sufficient to support a marketing authorization approval in all 27 European Union (EU) member states. In so doing, the EMEA agreed to the primary endpoint and the other principal design features of the new study. The EMEA's response is consistent with feedback previously received from United States Food and Drug Administration (FDA), paving the way for potential approval in the US and EU.

DOR and the FDA reached agreement on the design of the upcoming Phase 3 study via the Special Protocol Assessment (SPA) procedure. An agreement via the SPA procedure is an agreement with the FDA that a Phase 3 clinical trial's design (e.g., endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory submission seeking new drug approval.

Based on data from the prior Phase 3 study of orBec(R), the upcoming confirmatory Phase 3 clinical trial will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec(R) (i.e., 30 days following cessation of treatment). The confirmatory Phase 3 clinical trial wi
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