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Insmed Incorporated Message Board

  • jsblvbjb jsblvbjb May 18, 2014 2:58 PM Flag

    Late breaking abstract: 91% reenrollment

    [10:30 AM] Interim Analysis Of A Long-Term, Open-Label Safety, Tolerability, And Efficacy Study Of Liposomal Amikacin For Inhalation In Cystic Fibrosis Patients With Chronic Infection Due To Pseudomonas Aeruginosa, [Publication Page: A6571]
    Results: A total of 268 patients completed CLEAR-108, of which 206 (77%) were enrolled in CLEAR-110. The percentages of patients distributed according to age strata were: 6-12 years (21.8%), 12-18 years (27.7%), and 18 years (50.5%). The distribution of percentages of patients according to FEV1 % predicted strata was similar: 25-50% (30.6%), 50-75% (34.4%), and 75% (35.0%). All patients enrolled in CLEAR-110 have received at least 1 dose of LAI; of these, 92 patients received LAI in CLEAR-108 and 114 received TIS. As of December 31, 121 of 133 (91.0%) patients who have completed the first extension have consented to participate in the second extension. Analysis of safety data for patients who have completed week 48 will be available in the first quarter of 2014.

    Sentiment: Strong Buy

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