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[Tanaka]

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced topline biopsy data from study 28, the ongoing Phase 1b/2 clinical trial of AVI-4658, AVI's lead drug candidate being developed as a systemically administered treatment for a substantial subgroup of patients with Duchenne muscular dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. Topline biopsy data from the study demonstrated the first ever reported generation of new dystrophin-positive muscle fibers of more than 50% of normal in a patient with DMD following systemic administration of a drug. All patients in the two highest dose cohorts of the study demonstrated generation of new dystrophin-positive muscle fibers, although treatment responses varied across and within treatment groups. Generation of functional dystrophin is considered critical for successful treatment of DMD, and AVI intends further clinical evaluation of AVI-4658 to help optimize a dosing regimen to achieve more consistent improvements among patients.

Patients completing 12 weeks of treatment with six different doses of AVI-4658 (0.5, 1.0, 2.0, 4.0, 10 or 20 mg/kg) had their muscles biopsied before and after treatment, and analysis of the post treatment biopsy findings include:

Data reported today for the patients in the 10 and 20 mg/kg drug-treatment cohorts completing the 12 weekly doses (8 of 8 patients) showed consistent skipping of exon 51 in the dystrophin mRNA, providing evidence of systemic biologic activity of AVI-4658.

Three patients, one each in the 2.0, 10 and 20 mg/kg cohorts, demonstrated substantial generation of new dystrophin-positive muscle fibers, including the first ever reported generation of dystrophin-positive muscle fibers of more than 50% of normal in a patient following systemic administration of a drug.