DOR BioPharma, Inc. (DORB.OB) said Monday that it has reached an agreement with the U.S. Food and Drug Administration, or FDA, on the design of a confirmatory, pivotal Phase 3 clinical trial evaluating its lead product orBec or the treatment of acute gastrointestinal Graft-versus-Host Disease, or GI GVHD.
GI GVHD is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. orBec, an oral, locally acting therapy, is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD, DOR noted.
According to the Ewing, New Jersey-based company, the agreement was made under the FDA's Special Protocol Assessment, or SPA, procedure. An agreement via the SPA procedure is a deal with the FDA that a Phase 3 clinical trial's design is acceptable to support a regulatory submission seeking new drug approval. After the study begins, the FDA can only change a SPA for very limited reasons.
The company said that the upcoming confirmatory Phase 3 trial protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial, enrolling an estimated 166 patients. This trial is based on data from the prior Phase 3 study of orBec.
The primary endpoint of the study will be the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint in the previous Phase 3 study.
"With our primary endpoint of the 'treatment failure rate at Study Day 80,' we expect to replicate statistical significance in this clinically meaningful endpoint with orBec. We expect to initiate this trial in the first half of 2009, said Christopher Schaber, PhD, President and Chief Executive Officer of DOR.
"With the regulatory clarity received from FDA, we are now confident that we have a more clearly defined development path that has the potential to lead to regulatory approval of orBec. We are excited to move forward with this trial in an effort to address the significant unmet medical need of GI GVHD," Schaber added.
DORB.OB closed Friday's trading at $0.06.
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