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news.The National Cancer Institute (NCI) has announced a small business innovation research (SBIR) grant to Soligenix to support a Phase 2 trial of oral beclomethasone 17,21-dipropionate or BDP (orBec) as a treatment for chronic gastrointestinal (GI) manifestation of chronic Graft-versus-Host disease (GVHD).
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The two-year grant worth $300,000 will support Soligenix’s multicenter, open-label, pilot study enrolling patients that have received allogeneic hematopoietic cell transplantation at least 100 days earlier, have documented chronic GVHD in at least one organ outside the GI tract, and have a GI biopsy consistent with chronic GI GVHD.
Soligenix senior vice president and chief medical officer Kevin Horgan said, "We look forward to working with our clinical centers to initiate this study as soon as possible to continue development of orBec with the aim of addressing this critical unmet medical need."
The estimation of the proportion of subjects with chronic GI GVHD who achieve a complete response, partial response and overall response of GI GVHD signs and symptoms when treated with orBec for up to 16 weeks is the primary efficacy objective of the study, which is expected to be initiated in the first half of 2013.
Soligenix president and chief executive officer Christopher Schaber said, "To date, we have been fortunate to receive over $25 million in government support across both the BioTherapeutics and Vaccine/ BioDefense segments of our business, and currently have approximately $6 million in government funding remaining."