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Phase 2 trial begins for potential treatment of graft-versus-host disease
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Soligenix has initiated a randomized, double blind, placebo-controlled phase 2 trial for orBec, its potential treatment for gastrointestinal manifestations of chronic graft-versus-host disease, a company news release said.
The evaluation of orBec (oral beclomethasone 17,21-dipropionate, BDP) is partially funded by the National Cancer Institute, which awarded Soligenix a $300,000 Small Business Innovation Research grant. The funds will be paid out during the next 2 years.
“We are pleased by the continued support of NCI as a collaborator supporting our oncology focused BDP clinical programs,” Christopher J. Schaber, PhD, president and CEO of Soligenix, said in the release. “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.”
The multicenter pilot study will enroll allogeneic hematopoietic cell transplantation (HCT) patients who, at least 100 days after transplant, have chronic graft-versus-host disease (GVHD) documented in at least one organ outside the GI tract and have a mucosal biopsy consistent with GI GVHD, the release said.
Using a composite score targeting GVHD symptoms of satiety, nausea/vomiting and anorexia, the study is intended to determine the proportion of patients who achieve complete, partial or minimal response to the treatment during a 16-week period.
“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,” George B. McDonald, MD, of the University of Washington, said in the release. “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.”