Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that patient enrollment has been completed in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens. The study is being conducted by Paul Martin, MD at the Fred Hutchinson Cancer Research Center in Seattle, WA and is supported, in large part, by a National Institutes of Health (NIH) grant.
The Phase 2 trial enrolled 140 patients who have been randomized to either orBec® or placebo at a 2:1 ratio. The primary endpoint of this trial is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. Subjects in the orBec® group began study drug at the start of their conditioning regimen and continued through day 75 following HCT. Results from the Phase 2 study are expected in the second half of 2010.
"We are pleased to announce the important milestone of enrollment completion in this study aimed at preventing the potential morbidity associated with acute GVHD which is an unmet medical need," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We appreciate the efforts of the clinicians involved with the study led by Dr. Martin at the Fred Hutchinson Cancer Research Center, as well as the participation from the patients. We are looking forward with great anticipation to announcing the results of this study."
HEPA air purifiers fall short in cutting respiratory infections in aged-care facilities