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Insmed Incorporated Message Board

  • levonchiko levonchiko Feb 19, 2014 8:03 AM Flag

    Press release

    7:02 am Insmed provides interim update from two-year, open-label extension study of ARIKACE to treat pseudomonas aeruginosa in cystic fibrosis patients; initial 12-month data demonstrate long-term safety and durability of effect (INSM) :

    Co provided an interim update from the co's CLEAR-110 study, an ongoing, two-year, open-label extension study of once-daily ARIKACE, or liposomal amikacin for inhalation, to treat Pseudomonas aeruginosa in cystic fibrosis patients. These data are from 98 patients who have completed the first 12 months (six cycles) of the CLEAR-110 extension study. The data were collected as part of a scheduled data safety monitoring board (:DSMB) review of the CLEAR-110 extension study. The data showed that ARIKACE was well tolerated, and there was a sustained improvement from baseline level in Forced Expiratory Volume in One Second. These patients also experienced a sustained reduction in density of Pa sputum while on treatment.
    These data demonstrate that patients receiving ARIKACE for six cycles (12 months) in the extension study showed mean increase in relative change in FEV1 which is sustained during both on-treatment and off-treatment months. Overall, ARIKACE was well-tolerated during the six cycles administered over this 12-month period, with adverse events being consistent with those expected in a population of CF patients receiving inhaled medicines.

    Sentiment: Strong Buy

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