BioCentury
ARTICLE | Clinical News

AVI-7537 regulatory update

September 24, 2012 7:00 AM UTC

FDA granted Fast Track designation for Sarepta's AVI-7288 to treat Marburg virus infection and AVI-7537 to treat Ebola virus infection. Sarepta is developing the compounds, which are single oligomer nucleic acid analog based on morpholino-modified phosphorodiamidate oligomers (PMO) antisense chemistry, under a July 2010 contract from the U.S. Department of Defense's Transformational Medical Technologies (TMT) program (see BioCentury, July 19, 2010). The company is also developing the compounds under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. Next quarter, Sarepta plans to begin a multiple ascending-dose Phase I trial with AVI-7288 for Marburg virus infection. AVI-7537 is in Phase I testing to treat Ebola infection. ...