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Data Published in Muscle and Nerve Validates the Six-Minute Walk Test as an Outcome Measure in Duchenne Muscular Dystrophy
Date:12/8/2009

SOUTH PLAINFIELD, N.J., Dec. 8 /PRNewswire/ -- Data published online in the medical journal Muscle and Nerve support the use of the six-minute walk test (6MWT) as an outcome measure in PTC Therapeutics, Inc.'s ongoing registration-directed clinical trial of ataluren in patients with nonsense mutation Duchenne/Becker muscular dystrophy (nmDMD/BMD). The study results, which will also be published in an upcoming print issue of the journal, characterize the limitations on walking by patients with DMD relative to healthy boys and indicate that young boys can consistently and reliably perform the test. The data were obtained from an observational study conducted at the University of California Davis which was sponsored by PTC and supported by a grant from Parent Project Muscular Dystrophy (PPMD).

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The 6MWT is an accepted and standardized measure of muscle, lung, and heart health in patients with other medical conditions. However, the test had not previously been used to evaluate boys with DMD. The observational study was designed to confirm that boys with DMD would have the stamina and focus required to successfully and consistently complete the test without injury.

"Advancing the validation of clinically meaningful endpoints for therapeutic and natural history studies in DMD has been a focus of the Duchenne clinical and advocacy communities for many years," said Craig McDonald, M.D., principal investigator of the observational study and director of the Rehabilitation Research and Training Center in Neuromuscular Diseases, University of California Davis. "The publication of these findings demonstrates that the 6MWT can serve as a clinically meaningful outcome measure for documenting the evolution of the disease and the treatment benefits of new therapies for DMD.
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SOURCE PTC Therapeutics, Inc.
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