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

isease stages. Researchers will also evaluate a new endpoint that could make DMD studies faster, more precise, less expensive and inclusive of a larger group of boys. Presently, the six-minute walk (6MW) is the standard endpoint for DMD studies. However, the 6MW has shortcomings including variability and difficulty interpreting the clinical relevance of a given effect size. It also limits study participants to boys who can walk at a certain speed. There are no validated endpoints for very young boys with DMD. The proposed endpoint, electrical impedance myography (EIM), is a simple, non-invasive technique that can measure the health of a muscle and track its changes over time. As a validated endpoint for DMD, EIM would allow researchers to include a wide range of boys in studies and more effectively and rapidly understand how well a treatment is working to halt disease progression.

"Not only do we need several different categories of treatments for DMD—a therapeutic cocktail that might include different components depending on the stage of the disease—we also need new endpoints to improve the quality and speed of our clinical studies," said Dr. Diana Escolar, Associate Professor of Neurology at Johns Hopkins School of Medicine's Kennedy Krieger Institute, DART's Chief Medical Officer and Study Director. "It is only through this two-pronged approach that we will succeed in our mission to make DMD a chronic, manageable disease instead of a fatal one."

Affecting approximately 1 in 3,600 boys worldwide, DMD is the most common of the muscular dystrophies and the most lethal genetic disorder of childhood. It is caused by a genetic mutation that renders boys unable to make functional dystrophin, a protein critical for normal muscle function. Young men with DMD show progressive signs of physical impairment as early as age three, lose the ability to walk in their teens, and die of cardiac or respiratory fai
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