01.05.09
DOR BioPharma, Inc. has reached agreement with the FDA on the design of a confirmatory Phase III trial for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure.
The SPA is an agreement with the FDA regarding the trial's design, including endpoints, sample size, control group and statistical analyses. The design has been deemed acceptable to support a regulatory submission seeking new drug approval. Once the study begins, the FDA can only change an SPA for very limited reasons.
The confirmatory study will be a double-blind, randomized, placebo-controlled, multi-center trial that will enroll approximately 166 patients. The primary endpoint is the treatment failure rate at study day 80.
"We are very pleased to gain SPA agreement with the FDA," stated Christopher J. Schaber, Ph.D., president and chief executive officer of DOR. "The depth and strength of our available Phase III data have allowed us to design and power this pivotal trial that we believe maximizes orBec's chances for success. 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."
The SPA is an agreement with the FDA regarding the trial's design, including endpoints, sample size, control group and statistical analyses. The design has been deemed acceptable to support a regulatory submission seeking new drug approval. Once the study begins, the FDA can only change an SPA for very limited reasons.
The confirmatory study will be a double-blind, randomized, placebo-controlled, multi-center trial that will enroll approximately 166 patients. The primary endpoint is the treatment failure rate at study day 80.
"We are very pleased to gain SPA agreement with the FDA," stated Christopher J. Schaber, Ph.D., president and chief executive officer of DOR. "The depth and strength of our available Phase III data have allowed us to design and power this pivotal trial that we believe maximizes orBec's chances for success. 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."