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DART Therapeutics Initiates Study of HT-100 For Duchenne Muscular Dystrophy
Date:7/15/2013

CAMBRIDGE, Mass., July 15, 2013 /PRNewswire/ --DART Therapeutics Inc., an innovative, new-model biotechnology firm focused on developing therapies for Duchenne muscular dystrophy (DMD), has initiated a phase 1b/2a study of its lead drug candidate, HT-100 (delayed-release halofuginone). The phase 1b study (with a six-month 2a extension) in patients will determine the safety and tolerability of different, increasing doses of HT-100, and explore trends in a range of efficacy endpoints.    

HT-100 is an orally available, small molecule drug candidate intended to reduce fibrosis and inflammation and promote healthy muscle fiber regeneration in boys with DMD. The phase 1b/2a clinical program will enroll 30 boys and young men with DMD, both ambulatory and non-ambulatory. Participating centers include University of California, Davis Medical Center (Sacramento, Calif.), Kennedy Krieger Institute, Johns Hopkins School of Medicine (Baltimore, MD), Washington University School of Medicine (St. Louis, MO), Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio) and Nationwide Children's Hospital (Columbus, Ohio). DART expects to complete the study in mid 2014.

"Treating DMD requires a cocktail of therapies that will change over time," said Gene Williams, CEO of DART Therapeutics. "We believe HT-100 could be a valuable part of this cocktail—even a mini-cocktail on its own—because it demonstrates potential to address many different aspects of the disease in parallel, which could make it an exceptionally important therapy for all boys living with DMD."

DART's study will include boys aged six through 20, an atypical age range that allows investigators to evaluate HT-100's safety in a broad population as well as study its effect in different d
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SOURCE DART Therapeutics Inc.
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