PORTLAND, OR--(MARKET WIRE)--Feb 19, 2009 -- AVI BioPharma, Inc. (NasdaqGM:AVII - News), a developer of RNA-based drugs, today announced treatment of the first patient in a clinical trial evaluating the systemic delivery of AVI-4658 for the treatment of Duchenne muscular dystrophy (DMD). 

"We are very pleased to begin the systemic evaluation of our exon skipping drug -- AVI-4658 -- for the treatment of DMD," said Stephen Shrewsbury, M.D., Chief Medical Officer and Senior Vice President, Clinical and Regulatory Affairs of AVI BioPharma. "We believe that this trial will build significantly on the data generated by the successful recent trial evaluating intramuscular administration of the same drug in DMD boys."

The trial will enroll 16 ambulatory boys with DMD and initially evaluate multiple intravenous doses of AVI-4658 between 0.5 - 4.0 mg/kg. This is an open label, 12 week safety trial, which includes measures of drug efficacy and pharmacokinetics. The clinical study started in London, UK at the UCL Institute of Child Health / Great Ormond Street Hospital NHS Trust facilities by members of the MDEX Consortium led by Professor Francesco Muntoni and will shortly start to recruit patients in Newcastle Upon Tyne. AVI BioPharma is the sponsor for the trial and Professor Muntoni has been awarded funding support of $1.3 million from the UK Medical Research Council to offset some of the clinical costs of the trial.

In January 2009, AVI announced results from a Phase 1 trial evaluating the intramuscular administration of AVI-4658 for the treatment of DMD, also performed in collaboration with the MDEX Consortium. Biopsy data showed that injection of the drug into the muscles of a series of DMD patients successfully induced dystrophin production in a dose responsive manner. Further, the drug was well tolerated, with no significant drug-related adverse events. The Company was granted an orphan drug designation for AVI-4658 by the U.S. Food and Drug Administration in November 2007 and by the European Medicines Agency in December 2008.