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May 18, 2014
18:43 EDTITMNInterMune reports results from Phase 3 ASCEND study evaluating pirfenidone
InterMune reported that results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis, IPF, were presented at the International Conference of the American Thoracic Society, ATS, in San Diego, and published on-line in the New England Journal of Medicine. Dr. Talmadge King, Professor and Chair, Department of Medicine, University of California, San Francisco and Co-chair of the ASCEND protocol steering committee, presented the ASCEND results. In ASCEND, pirfenidone significantly reduced decline in lung function as measured by change in percent predicted forced vital capacity, FVC, from Baseline to Week 52. Additionally, significant treatment effects were demonstrated on both of the key secondary endpoints of change in six-minute walk distance and progression-free survival, PFS. The secondary endpoint of dyspnea , shortness of breath, was not met. In ASCEND, treatment with pirfenidone was associated with fewer deaths although the study was not powered for and did not reach statistical significance on mortality. A pre-specified analysis of the pooled population from ASCEND and the two Phase 3 CAPACITY studies showed that the risk of all-cause mortality was reduced by 48% at Week 52 in the pirfenidone group compared to the placebo group. In ASCEND, treatment with pirfenidone showed a favorable safety profile and was generally well tolerated.
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July 21, 2014
11:19 EDTITMNInterMune July weekly volatility elevated
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July 17, 2014
12:42 EDTITMNInterMune receives FDA Breakthrough Therapy Designation for pirfenidone
InterMune announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. FDA. This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis.

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