Soligenix, Inc., (Soligenix or the Company) (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). The initiation of enrollment in this trial also triggered the payment and receipt by Soligenix of a $1 million milestone pursuant to the Company's collaboration agreement with Sigma-Tau Pharmaceuticals, Inc.
This Phase 3 clinical trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec(®) Randomized Treatment Study), will enroll an estimated 166 patients to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. 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 Company's previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec(®) (i.e., 30 days following cessation of treatment). The SUPPORTS trial will be conducted at major transplant centers throughout the US and is expected to complete with clinical data available in the first half of 2011.
The SUPPORTS trial will be conducted pursuant to a Special Protocol Assessment (SPA) agreement that the Company had reached with the US Food and Drug Administration (FDA). 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. The European Medicines Agency (EMEA) also 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.