DOR BioPharma Announces Publication of orBec(R) Clinical Pulmonary Data in Bone Marrow Trans...(ryptogenic organizing pneumonia as compa...)

The investigators, led by Dr. Jason Chien, reviewed data from two previous randomized, double-blind, placebo-controlled Phase 2 and 3 clinical trials evaluating orBec(R), for the treatment of acute GI GVHD. Data from 120 patients (sixty patients treated with orBec(R), sixty placebo) were available for this retrospective analysis. Patients were enrolled in these studies at the Fred Hutchinson Cancer Research Center, where pulmonary function testing is done prospectively and all patients with pulmonary complications are evaluated with a standard protocol. The investigators also evaluated adverse event reports of infectious and non-infectious inflammation of the lung.

These observations by Dr. Chien and colleagues on the preservation of pulmonary function among patients receiving orBec(R) is consistent with findings from the Phase 3 randomized trial reported by Hockenbery et al. (A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood 109: 4557 - 4563, 2007).

"While these trials were not designed to look at pulmonary endpoints, these observations suggest that a metabolite of oral BDP may be having a beneficial anti-inflammatory effect in the lungs of hematopoietic cell transplant recipients," stated Jason W. Chien, MD, MS, Assistant Member, Clinical Research Division of the Fred Hutchinson Cancer Research Center. "There was convincing evidence of preservation of lung function and an absence of non-infectious pulmonary disease in those who had received oral BDP. The explanation for this benefit appears to be related to the delivery of a small amount of the potent metabolite, 17-beclomethasone monopropionate, from the intestinal mucosa to the pulmonary artery via the p
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