Drug Development

Positive new survival findings reported from phase II, III trials of orBec

Published in Drug Week, February 24th, 2006

Dor BioPharma, Inc., (DOR) announced that as part of its process to submit a New Drug Application (NDA) for oral beclomethasone dipropionate (orBec) for the treatment of patients with gastrointestinal Graft-versus-Host disease (iGVHD) and in response to a specific U.S. Food and Drug Administration (FDA) request, it has completed an analysis.

The analysis compares the statistically significant survival benefit demonstrated in favor of orBec in its pivotal phase III clinical trial to the survival results of the earlier successful 60 patient, randomized, double-blinded, placebo-controlled, phase II clinical trial of oral beclomethasone dipropionate for iGVHD.

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Source: Drug Week (2006-02-24)

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