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www.fdanews.com/articles/72584-decode-launches-phase-ii-clinical-trial-in-asthma

DeCODE Launches Phase II Clinical Trial in Asthma

May 23, 2005

DeCODE genetics has begun dosing of patients in a Phase II clinical trial in asthma.

The company has isolated a gene that plays an important role in the development of asthma. The gene encodes a kinase, which is the target of the compound that will be tested in the trial. The compound was developed by third party for the treatment of a different indication. The trial is randomized, double-blind and placebo-controlled, and will enroll approximately 160 asthma patients with the at-risk variants of the gene. The study cohort will be divided evenly into four groups, three receiving various doses of active drug and one receiving placebo.

The study will examine safety and tolerability, as well as the effectiveness of the various dose levels on improving lung function and reducing airway inflammation, as measured by spirometry tests, exhaled nitric oxide levels, biomarkers in sputum, as well as bronchial provocation tests. Patients will be on the drug for eight weeks, and deCODE expects to announce the results of the trial in the fall. Neither the name of the partner company nor the compound has been disclosed.