Gilead's Head-to-Head Study Of Cayston Vs. TIS In Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint Of Non-inferiority

Gilead's Head-to-Head Study Of Cayston Vs. TIS In Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint Of Non-inferiority -
6/18/2010 12:51 PM ET

(RTTNews) - Gilead Sciences, Inc. (GILD: News ) said Friday that its head-to-head Phase III clinical trial of Cayston compared to tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second percent predicted after 28 days of treatment.

Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.35% compared to 0.55% for patients receiving tobramycin inhalation solution, which meets the statistical definition of superiority. Safety results were similar across both arms of the study, with lower incidence of cough in patients receiving Cayston.

Cayston was approved by the U.S. Food and Drug Administration in February 2010 and by the Australian Therapeutic Goods Administration in January 2010. Cayston received conditional marketing authorizations in the European Union and Canada in September 2009. These conditional approvals are contingent upon results from this Phase III study.

Gilead said it plans to begin submitting data from this study to regulatory agencies later this year.

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by RTT Staff Writer

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