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Sarepta Therapeutics Inc announces positive safety results from phase i clinical study of marburg drug candidate


Monday, 10 Feb 2014 08:30am EST 

Sarepta Therapeutics Inc:Says positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers.Says AVI-7288, which uses Sarepta's advanced PMO plus chemistry, is the company's drug candidate for the treatment of Marburg virus infection.Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing.In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days.Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events.An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288. 

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