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PTC Therapeutics Announces Data Supporting Cough Frequency as a New Outcome Measure in Evaluating Treatments for Cystic Fibrosis
Date:5/21/2008

velopment efforts would benefit from reliable quantitative endpoints that are clinically meaningful because they directly measure changes in how a patient feels and functions.

"The ability to quantify cough represents a significant step forward in our understanding of one of the most prominent symptoms of CF," added Preston Campbell, III, M.D., Executive Vice President of Medical Affairs at the Cystic Fibrosis Foundation. "A significant reduction in cough frequency would be of real value to patients."

The study was designed to assess cough frequency as a measure of clinical benefit. Quantitative measurement was achieved using a new technology, the VivoMetrics(R) LifeShirt(R), which integrates cough signals from chest wall motion transducers and a throat microphone and stores the data for computer analysis. FEV1 (Forced Expiratory Volume in the first second) and FVC (forced vital capacity) -- key measures of lung function -- were assessed by spirometry, and patients completed a symptom survey.

Patients included 19 adults not in CF exacerbation. Although there was occasional neck pressure due to the throat microphone, compliance was excellent, with cough data collected for a median of 24 hours. Cough frequency averaged 643 coughs per day (ranging from 324 to 1,569 coughs per day) and tended to increase with lower FEV1 and greater age.

"Anecdotal information concerning cough frequency in CF patients led us to assess cough quantitatively using the LifeShirt(R)," said Langdon Miller, M.D., Chief Medical Officer of PTC. "The cough frequency data announced today highlights the potential for cough assessment as an outcome measure that may be used in the development of new therapies for CF. We look forward to presenting data on the effect of PTC124 on cough frequency at the 31st annual European Cystic Fibrosis Society Conference in June, and to initiating longer-term trials later this year to further evaluate the clinical efficacy of PTC124 in pat
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SOURCE PTC Therapeutics, Inc.
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