Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec® (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal (GI) manifestations of chronic Graft-versus-Host disease (GVHD). The study is partially funded by the National Cancer Institute (NCI) which has awarded Soligenix a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 2 clinical trial. The award provides Soligenix with approximately $300,000 over a two-year period.
The Phase 2 study is designed as a multicenter, pilot study enrolling patients that have received allogeneic hematopoietic cell transplantation (HCT) at least 100 days earlier, have documented chronic GVHD in at least one organ outside the GI tract, and have a mucosal biopsy consistent with GI GVHD. The primary efficacy objective of the study is to estimate the proportion of subjects with chronic GVHD with GI involvement who achieve a complete response, partial response or minimal response of GI GVHD signs and symptoms when treated with orBec® for up to 16 weeks. Response will be assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia.
"Survival of patients undergoing allogeneic HCT has markedly improved over the last decade, leading to a growing number of long-term survivors with chronic GVHD. In these patients, gastrointestinal GVHD can be a persistent problem whether layered on top of extraintestinal chronic GVHD or dominating the clinical picture," stated George B. McDonald, MD, Member, Fred Hutchinson Cancer Research Center and Professor of Medicine at the University of Washington. "Based on the pharmacology of orally-delivered BDP, which delivers a potent glucocorticoid directly to the GI mucosa, orBec® offers a promising option to address disabling GI symptoms in patients with chronic GVHD."
"We are pleased by the continued support of NCI as a collaborator supporting our oncology focused BDP clinical programs," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to working with our clinical centers to complete this study as soon as possible to continue development of orBec® with the aim of addressing this orphan disease."