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Insmed Incorporated Message Board

  • korking30 korking30 Jun 9, 2013 4:42 PM Flag

    was it PRd when the phase 3 trial ended? P3 data out this month?

    do we know how long they estimated it would take to tabulate the results and when the trial exactly ended?

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    • Is this what you are referring to?

      November 13, 2012

      Insmed Announces CLEAR-108 Phase 3 Clinical Study of ARIKACE® in Cystic Fibrosis Patients with Pseudomonas Lung Infections Has Completed Target Enrollment

      MONMOUTH JUNCTION, N.J., Nov. 13, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company focused on developing inhaled therapeutics for serious diseases of the lung, today announced that the Company's CLinical Evaluation of ARIKACE (CLEAR-108) phase 3 European and Canadian registrational study of ARIKACE® (liposomal amikacin for inhalation) for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections has now enrolled over 300 patients.

      CLEAR-108 is a randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), to TOBI® (1) (tobramycin solution for inhalation), which is a commercially available inhaled antibiotic that is delivered twice daily. The study is being conducted in over 300 patients in Europe and Canada.

      "The completion of enrollment in this pivotal phase 3 clinical trial represents an important milestone for Insmed as we advance ARIKACE closer to commercialization," said Will Lewis, President and CEO of Insmed. "We continue to expect top-line data from CLEAR-108 to be available in mid-2013."

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