AVI BioPharma Provides Update on Initiation of Eteplirsen Phase 2 Clinical Trial

AVI BioPharma, Inc. AVII, a developer of RNA-based therapeutics, today provided an update on the initiation of its Phase 2 clinical trial of eteplirsen, the Company's lead therapeutic candidate for the treatment of Duchenne muscular dystrophy . On June 8th, following a meeting of the Institutional Review Board of Nationwide Children's Hospital in Columbus, Ohio, the site of the Phase 2 clinical trial, AVI received an IRB request to modify the clinical trial protocol. AVI is reviewing the request, which is not related to the safety or expected activity of eteplirsen, and anticipates submitting a revised Phase 2 clinical trial protocol to he IRB later this month. The U.S. Food and Drug Administration (FDA) has not communicated any concerns regarding the original design of the Phase 2 clinical trial at this time and the Company intends to provide any updates on this protocol to the FDA. "We will work quickly and deliberately to address the IRB's request, and we expect to initiate the Phase 2 trial in the third quarter," said Chris Garabedian, AVI's President and CEO. "Furthermore, we are confident that we will remain on track in initiating a pivotal trial in the second half of 2012. We remain fully committed to eteplirsen development and its potential as an important treatment for DMD."