PRINCETON, N.J., Sept. 4, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the National Cancer Institute (NCI) has awarded Soligenix a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 2 clinical trial designed to evaluate orBec® (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal (GI) manifestation of chronic Graft-versus-Host disease (GVHD). The award will provide Soligenix with approximately $300,000 over a two-year period.
The Phase 2 study is designed as a 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. The primary efficacy objective of the study is to estimate 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. The study is expected to be initiated in the first half of 2013.
"We are pleased by the continued support of NCI as a collaborator supporting our oncology focused BDP clinical programs," stated Kevin J. Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix. "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."
"We believe that our success in securing this type of highly competitive funding is driven by the strength of our science and development capabilities," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "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. We will continue to execute on our strategy of identifying and applying for new non-dilutive funding opportunities wherever appropriate."About Chronic GVHD Graft-versus-Host disease (GVHD) is a major complication of allogeneic hematopoietic cell transplantation. GVHD is an inflammatory disease initiated by T cells in the donor graft that recognize histocompatibility and other tissue antigens of the host, and is mediated by a variety of effector cells and inflammatory cytokines. GVHD presents in both acute and chronic forms. The symptoms of chronic GVHD typically present at between 100 days and three years post-transplant.