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news.InterMune has announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis.
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The roll-over study will be open to patients who complete one of the two concurrent Phase III Capacity studies of pirfenidone in idiopathic pulmonary fibrosis (IPF). InterMune expects that the first patient will enter the roll-over study in August 2008.
Regarding the progress of Capacity, the company noted that patient retention and overall study conduct remain excellent, with a low rate of patient dropouts to date. InterMune anticipates that top-line results from Capacity will be available in January 2009. Data from the Capacity trials will remain blinded during the extension study enrollment period.