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June 3, 2014
07:04 EDTARDMAradigm receives $5M milestone for dosing of first patient in Phase III study
Aradigm Corporation announced that it has received the $5M milestone payment from Grifols S.A. for the dosing of the first patient in the ORBIT-3 Phase III pivotal clinical trial of Aradigm’s proprietary formulation of inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis. The Phase III clinical program for Pulmaquin in BE consists of two worldwide, double-blind, placebo-controlled pivotal trials that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial will enroll approximately 255 patients into a 48 week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28-day open label extension in which all participants will receive Pulmaquin. The superiority of Pulmaquin vs. placebo during the double blind period will be evaluated in terms of the time to first pulmonary exacerbation, while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function will be monitored as a safety indicator. The first patient in the ORBIT-3 trial was dosed on April 29.
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