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PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
Date:6/12/2008

clinical trials at high and low doses of PTC124, TEPD assessments showed statistically significant improvements of mean CFTR-dependent chloride secretion in the airways.

The Phase 2a extension study in Israel assessed 3 months of oral PTC124 therapy at two different dose levels in 19 adult men and women with nonsense- mutation-mediated CF who had participated in a prior short-term PTC124 Phase 2a study. More than 90% of the patients had chronic CF-related lung infection and also had CF-induced pancreatic insufficiency. Results from the study showed that treatment with PTC124 resulted in statistically significant (p< 0.001) improvements in CFTR function as measured by TEPD in both dose groups. The proportion of patients showing improvement in TEPD chloride secretion increased over time in the extension study. Trends towards improvements in mean FEV1 and FVC values were observed. Baseline data showed that CF patients cough a remarkable 643 times per day on average, with a range of 324 to 1,569 coughs per day. In comparison, healthy individuals generally cough fewer than 16 times per day, according to the European Respiratory Journal (Hsu 1994). Patients receiving PTC124 experienced a mean [28%] decrease in cough frequency by the end of three months of therapy (p< 0.01). PTC124 was generally well tolerated, resulting in excellent mean compliance with the treatment regimen ( >90%).

"Three months of treatment with PTC124 in nonsense-mutation-mediated CF patients was associated with time-dependent improvements in nasal TEPD chloride conductance, pulmonary function and cough -- important markers suggesting the potential for benefit in patients with CF," stated Dr. Wilschanski. "PTC124 increases CFTR-mediated chloride secretion in patients with a variety of nonsense mutation types, which suggests a broad spectrum of activity across one of the major subpopulations in CF."

Dr. Kerem added, "The impact on cough that we observed in this study by objective
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SOURCE PTC Therapeutics, Inc.
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