Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.
The grant will be used to defray a significant portion of the costs associated with the conduct of the Company's ongoing, confirmatory, Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host-Disease (GI GVHD). This trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec® Randomized Treatment Study), will enroll an estimated 166 subjects to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint in the SUPPORTS protocol 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 Phase 3 study includes major stem cell transplantation centers in the United States, Europe and Australia, and is expected to complete in the first half of 2011.
"We are grateful to have been awarded this significant grant to support our ongoing confirmatory Phase 3 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe the award is a validation of the design of our Phase 3 trial and a clear indicator of the importance of orBec® and its potential application in the treatment of acute GI GVHD. Through the award of this grant, the FDA clearly recognizes the need for treatment options in the unmet medical need of GVHD. As a result, orBec® could become the first FDA-approved therapy to treat and prevent GVHD."
In addition to issued patents and pending worldwide patent applications, orBec® benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, as well as an orphan drug designation in the U.S. for the prevention of acute GVHD and the treatment of chronic GI GVHD. Orphan drug designations provide for 7 and 10 years of market exclusivity upon approval in the U.S. and Europe, respectively. In the U.S., orphan drug designations also make the Company eligible for research funding provided by OOPD, in addition to receiving tax credits for certain research expenses and a waiver of expensive FDA application user fees.
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