Clinical Trials
Positive new survival findings reported from phase II and III clinical trials of orBec
Published in Medical Letter on the CDC and FDA, February 19th, 2006
DOR BioPharma, Inc., (DOR) announced that as part of its process to submit a new drug application for orBec (oral beclomethasone dipropionate) for the treatment of patients with gastrointestinal graft-versus-host disease (iGVHD) and in response to a specific U.S. Food & Drug Administration (FDA) request, it has completed an analysis to compare 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.
Details of these new findings...
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