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PTC Announces Data Showing That PTC124 Causes Statistically Significant Improvements in Chloride Channel Function in Cystic Fibrosis Patients
Date:10/24/2008

ted chloride channel activity as measured by nasal potential difference, with 40 percent of patients achieving values in the normal range during PTC124 administration. The study demonstrated improvements in patients with multiple nonsense mutation types and indicated a similar PTC124 pharmacokinetic profile as that seen in previous studies in adults. PTC124 was generally well tolerated in this study and compliance was greater than or equal to 93 percent.

"We are encouraged by the results of this study showing PTC124 to be as pharmacologically active and well tolerated in children with CF as it is in adults," said Dr. Sermet-Gaudelus. "There is a serious need for new methods to treat the underlying cause of CF, particularly in younger patients who have not yet experienced irreversible disease-related lung injury. These data in pediatric patients support inclusion of children with CF in long-term studies of PTC124."

Israeli Phase 2a 12-Week Study Results

The Phase 2a extension study evaluated 12 weeks of oral PTC124 at two different dose levels in 19 adults with nonsense-mutation CF who participated in a prior short-term PTC124 Phase 2a study. Greater than 85 percent of the patients had chronic CF-related lung infection and pancreatic insufficiency. Study results showed that treatment with PTC124 resulted in statistically significant improvements in CFTR function as measured by nasal potential difference in both dose groups. Improvements in lung function, including forced expiratory volume in one second (FEV1) and forced vital capacity (FVC), were also observed. Baseline data showed that the patients coughed a remarkable 630 times per day on average, with a range of 320 to 1,330 coughs per day, compared to healthy individuals who typically cough fewer than 16 times per day, according to the European Respiratory Journal (Hsu 1994). Patients in this study experienced a mean decrease in cough frequency of almost 200 coughs per day by the end of the s
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SOURCE PTC Therapeutics, Inc.
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