AVI BioPharma AVII, a developer of RNA-based therapeutics, today announced that
the United States Adopted Names Council has approved the nonproprietary name eteplirsen for AVI-4658, the Company's exon-skipping therapy for the treatment of Duchenne muscular dystrophy, a genetic muscle wasting disease caused by the absence of functional dystrophin. In addition, the World Health Organization has approved eteplirsen as the International Nonproprietary Name for AVI-4658.
AVI has announced plans to initiate a Phase 2 study of eteplirsen in
June, and is currently conducting NDA-enabling activities to prepare
for the initiation of a pivotal study in the second half of 2012.
These activities include the initiation of additional animal
toxicology studies to allow for long-term dosing and the
implementation of large-scale GMP production processes to have drug
supply available for the pivotal study.
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