daclizumab improves pulmonary function in asthma

Inpharma 1429 - 20 Mar 2004 ■ The humanised anti-CD25 monoclonal antibody daclizumab * has improved pulmonary function in a double-blind phase II asthma trial. Patients with chronic, persistent asthma whose disease was not well controlled with high doses of inhaled corticosteroids (n = 114) were randomised in a 3:1 ratio to receive ten doses of daclizumab or placebo at 2-weekly intervals in addition to inhaled corticosteroids. Daclizumab was administered as an initial IV dose of 2 mg/kg followed by subsequent IV doses of 1 mg/kg. At 12 weeks, patients receiving daclizumab experienced a mean increase in FEV1 of 4.4% of baseline, compared to placebo patients who experienced a mean decrease of 1.5% (p = 0.05). Secondary clinical endpoints supported these findings. * Protein Design Labs; phase II in the US for asthma. Daclizumab has been launched for renal transplant rejection. Protein Design Labs Inc. Protein Design Labs Reports Positive Results in Phase II Clinical Trial Of Daclizumab in Asthma. Media Release : 15 Mar 2004. Available from: URL: http://www.pdl.com 809032341 1 Inpharma 20 Mar 2004 No. 1429 1173-8324/10/1429-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: Daclizumab improves pulmonary function in asthma

Inpharma 1429 - 20 Mar 2004

■ The humanised anti-CD25 monoclonal antibodydaclizumab* has improved pulmonary function in adouble-blind phase II asthma trial. Patients withchronic, persistent asthma whose disease was not wellcontrolled with high doses of inhaled corticosteroids(n = 114) were randomised in a 3:1 ratio to receiveten doses of daclizumab or placebo at 2-weeklyintervals in addition to inhaled corticosteroids.Daclizumab was administered as an initial IV dose of2 mg/kg followed by subsequent IV doses of 1 mg/kg.At 12 weeks, patients receiving daclizumabexperienced a mean increase in FEV1 of 4.4% ofbaseline, compared to placebo patients whoexperienced a mean decrease of 1.5% (p = 0.05).Secondary clinical endpoints supported these findings.* Protein Design Labs; phase II in the US for asthma. Daclizumabhas been launched for renal transplant rejection.

Protein Design Labs Inc. Protein Design Labs Reports Positive Results inPhase II Clinical Trial Of Daclizumab in Asthma. Media Release : 15 Mar2004. Available from: URL: http://www.pdl.com 809032341

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