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Halo Therapeutics' HT-100 Receives FDA's Orphan Designation for Duchenne Muscular Dystrophy
Date:1/4/2012

olio at Genzyme and founding multiple life science and healthcare companies. 

"We are in a race against time to find safe and effective therapies for boys with DMD," said Benjamin Seckler, MD, President of Charley's Fund. "Our partnering with Nash Avery Foundation to establish Halo Therapeutics is the next step in the DMD patient community's tireless effort to find such a therapy. We're excited to have Gene and Marc, experienced drug development and biopharma industry business professionals, leading the company."

HT-100 works by inhibiting the pathological fibrotic process in muscle and directly stimulating healthy muscle fiber regeneration. The company has acquired an extensive data package on HT-100 including results of numerous animal model studies, a comprehensive toxicology package, and human clinical data from multiple trials in healthy volunteers and select disease populations.

Planning is well underway for clinical evaluation of the compound. CEO Marc Blaustein said, "We're extremely pleased that HT-100 has received orphan drug designation. This adds momentum to the significant progress we've made since our founding, and we are pressing forward to initiate a Phase II clinical trial in 2012 to evaluate HT-100 in DMD patients."About Duchenne Muscular DystrophyDuchenne muscular dystrophy is caused by a mutation in the dystrophin gene, resulting in progressive muscle weakness. The disease manifests itself first in weakened skeletal muscles and eventually results in cardiac and pulmonary impairment. Corticosteroids are the current standard of care treatment for DMD.  While this treatment delays disease progression by several years, their prolonged use is typically associated with side effects and the treatment does not alter the ultimate outcome of the disease. Young men with Duchenne typically live into their twenties or early thirties.

About Halo TherapeuticsBased in Newton, Mass., Halo Therapeutics, LLC, is a clinical
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SOURCE Halo Therapeutics, LLC
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