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June 4, 2014
08:01 EDTVRTXVertex reports improvement in lung function in proof-of-concept ivacaftor study
Vertex Pharmaceuticals announced the results of a two-part proof-of-concept study of ivacaftor in 24 people with cystic fibrosis who have a residual function mutation. The first part of the study evaluated ivacaftor, compared with placebo, in a two-week crossover design over two treatment cycles, and the second part of the study evaluated ivacaftor in an eight-week open-label design. In part one, a statistically significant improvement in mean absolute lung function was observed after treatment with ivacaftor for two weeks compared with placebo. In part two of the study, improvements in lung function were observed after eight weeks of treatment. In the study, ivacaftor was generally well-tolerated, and the most common adverse events in the treatment group were cough and respiratory tract infection. This proof-of-concept study was the first to evaluate the use of ivacaftor in multiple residual function mutations and is supported by in vitro observations that showed ivacaftor enhanced the function of the cystic fibrosis transmembrane conductance regulator protein in cells with residual function mutations. Based on these data, Vertex plans to initiate a larger Phase 3 study in people with residual function mutations that will evaluate longer-duration treatment with ivacaftor, pending discussions with regulatory authorities.
News For VRTX From The Last 14 Days
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December 15, 2014
09:06 EDTVRTXVertex names David Altshuler as Chief Scientific Officer
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December 12, 2014
08:01 EDTVRTXPiper predicts two large-cap biotechs could be acquired in 2015
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December 11, 2014
07:28 EDTVRTXCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.

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