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FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2006--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase III AIR-CF2 (CP-AI-005) study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa
(P. Aeruginosa) met its primary efficacy endpoint, the time to need for inhaled or intravenous (IV) antibiotics, which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation. Data from the 247-patient study demonstrated a significant improvement in time to need for inhaled or IV antibiotics after a 28-day treatment course of aztreonam lysine for inhalation compared to placebo, both following a 28-day treatment course of tobramycin inhalation solution (pooled p-value=0.007 by log rank test). The primary efficacy endpoint analyzed the pooled data from both aztreonam treatment arms, as pre-specified under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). Full study results will be submitted for presentation at an upcoming scientific meeting.
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FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2006--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase III AIR-CF2 (CP-AI-005) study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa
(P. Aeruginosa) met its primary efficacy endpoint, the time to need for inhaled or intravenous (IV) antibiotics, which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation. Data from the 247-patient study demonstrated a significant improvement in time to need for inhaled or IV antibiotics after a 28-day treatment course of aztreonam lysine for inhalation compared to placebo, both following a 28-day treatment course of tobramycin inhalation solution (pooled p-value=0.007 by log rank test). The primary efficacy endpoint analyzed the pooled data from both aztreonam treatment arms, as pre-specified under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). Full study results will be submitted for presentation at an upcoming scientific meeting.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.paripharma.com/news2u.htm">http://www.paripharma.com/news2u.htm</a>