AVI BioPharma Provides Update on Initiation of Eteplirsen Phase 2 Clinical Trial
Avi Biopharma (NASDAQ:AVII)
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Today : Thursday 9 June 2011
AVI BioPharma, Inc. (NASDAQ: 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 (DMD).
On June 8th, following a meeting of the Institutional Review Board (IRB) 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 the 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."
Based on the expected initiation of the Phase 2 trial in the third quarter, AVI anticipates study results in the second quarter of 2012.
About Institutional Review Boards
Institutions conducting clinical trials must submit each trial protocol to an independent institutional review board for review and approval prior to trial initiation. Generally, the institutional review boards will consider, among other things, clinical trial design, participant informed consent, ethical factors, the safety of human subjects, and the possible liability of the institution. While institutional review boards are mandated and overseen by the U.S. Department of Health and Human Services and FDA, they are not affiliated with either of these governmental entities.
About Eteplirsen
Eteplirsen is AVI's lead systemically administered drug candidate for the treatment of a substantial subgroup of patients with Duchenne muscular dystrophy (DMD). Data from clinical studies of eteplirsen in DMD patients have demonstrated a broadly favorable safety and tolerability profile and restoration of dystrophin protein expression. AVI plans to initiate a Phase 2 study of eteplirsen in the third quarter of 2011 and is currently conducting NDA-enabling activities to support the initiation of a pivotal Phase 3 study in the second half of 2012.
