Soligenix, Inc. (Soligenix or the Company) (OTC BB: SNGX), a development stage biopharmaceutical company, announced the publication of results from its investigator-initiated Phase 2 "proof-of-concept" exploratory clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period. The article is entitled "Evaluation of Oral Beclomethasone Dipropionate for the Prevention of Acute Graft-versus-Host Disease" and is posted online in Biology of Blood and Marrow Transplantation.
As previously reported, orBec® appears safe and well tolerated in this patient population, but did not achieve statistical significance in the primary endpoint, which was the proportion of subjects who developed acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. As detailed in the article, this result was possibly due to poor patient compliance with administration of study drug which was lower than anticipated with only 54% of patients taking at least 90% of study drug within 4 weeks of transplantation.
It was noted that poor compliance in the study may be associated with the incidence of oral mucositis, as a lower severity of oral mucositis was highly correlated with better compliance (p <0.0001). Compliance was also better in patients who did not require systemic treatment for GVHD in the orBec® arm (p = 0.001) compared to those in the placebo arm (p = 0.98), consistent with the possibility that reduced adherence may have compromised the orBec® treatment effect. Among the 50 orBec® patients with at least 90% compliance, 54% required systemic treatment for GVHD, versus 65% of the 26 placebo patients with at least 90% compliance. The mean cumulative dose of prednisone was 28.8 mg/kg among all orBec® patients with at least 90% compliance, versus 37.1 mg/kg among all placebo patients with at least 90% compliance. For the group with less than 90% compliance, the mean cumulative prednisone dose was the same in both arms.
Kevin Horgan, MD, Chief Medical Officer of Soligenix commented, "Upon deeper analysis of the data from the Phase 2 prevention study, we find that poor overall patient compliance may have played a role in the equivocal primary endpoint result. This observation is interesting and consistent with the previously reported overall decrease in the incidence of the more severe grades of GVHD and indicative of a preventive effect for orBec® in this setting. However, I would caution that this analysis is exploratory and needs to be analyzed in light of the failure of the recent Phase 3 treatment clinical trial in acute gastrointestinal GVHD to achieve its primary endpoint. We will provide information on the future of the overall GVHD program once the data from the Phase 3 trial has been fully analyzed."
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