Gilead Sciences, Inc. (GILD) Head-to-Head Study of Cayston(R) Versus Tobramycin Inhalation Solution in Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint of Non-Inferiority
6/18/2010 11:03:03 AM
VALENCIA, Spain--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its head-to-head Phase III clinical trial of Cayston® (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) 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 percent compared to 0.55 percent for patients receiving TIS, 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. These data were presented during a late-breaker oral session today at the 33rd European Cystic Fibrosis Conference (ECFC) in Valencia, Spain.
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