PTC Therapeutics initiates Phase III cystic fibrosis trial

Fri. September 11, 2009; Posted: 11:23 AM

Sep 11, 2009 (Datamonitor via COMTEX) -- PTCT | Quote | Chart | News | PowerRating -- PTC Therapeutics, a biopharmaceutical company, has initiated a Phase III trial of ataluren, an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis or nmCF.

The primary objective of the registration-directed double-blind, placebo-controlled study is to evaluate whether ataluren can improve lung function, as measured by forced expiratory volume in one second (FEV1), in patients with nmCF. Other outcome measures will evaluate whether ataluren can reduce symptoms associated with nmCF, decrease lung infections, reduce the frequency of cough, and improve patient-reported quality of life.

The 48-week trial is now enrolling patients at multiple research centers in North America, Europe, and Israel. Study candidates include patients who are at least six years of age and have cystic fibrosis (CF) due to a nonsense mutation.

Langdon Miller, chief medical officer of PTC Therapeutics, said: "We are excited to expand the ataluren registration program to include nmCF, an area of significant unmet medical need.

"We are hopeful that this Phase III trial together with our ongoing studies in nonsense mutation Duchenne muscular dystrophy/Becker muscular dystrophy, will add to a growing body of data demonstrating ataluren's potential for treatment of patients with nonsense mutation genetic disorders."

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