August 24, 2010 (FinancialWire) — Soligenix, Inc. (OTCBB: SNGX), a late-stage biopharmaceutical company, said that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development of the U.S. Food and Drug Administration under its Orphan Products Development Program.

According to Soligenix, 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.

The 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 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.

The goal of FDA's OPD Program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy.

FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.

New Jersey-based Soligenix develops products to treat side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.

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