AVI Biopharma (AVII) Updates Preliminary Safety Data on AVI-4658 at 7th Annual Duchenne Conference

October 26, 2009 8:16 AM EDT

AVI BioPharma, Inc. (NASDAQ: AVII) presented an update on preliminary safety data from its ongoing systemic Phase 1b/2 clinical trial of exon skipping AVI-4658 in patients with Duchenne muscular dystrophy (DMD) at the 7th Annual Action Duchenne Conference in London, UK.

The most recent data from the ongoing Phase 1b/2 trial at two MDEX sites in the UK demonstrate that AVI-4658 was well tolerated by DMD patients in a dose escalation study that is now up to the fifth cohort (10 mg/kg). Results from the 12 week dosing periods of the first four completed cohorts (0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg and 4.0 mg/kg) have been reviewed with data from the ongoing cohort 5 (10 mg/kg) and have demonstrated the drug to be well tolerated. There have been no safety issues identified, although one Serious Adverse Event was reported due to an anaesthetic-induced post-treatment biopsy procedure at 14 weeks, 2 weeks after last dose, causing nausea and vomiting.

The maximum cumulative dose administered to date is 2797 mg and the maximum single dose is 300 mg with no signs of intolerance, in either case. Blood tests, including measures of coagulation, have remained satisfactory, with the elevated levels of muscle enzyme, creatine kinase tending to fall in most boys during treatment. Lung function, vital signs and examinations have also remained stable. In addition, no significant side effects from the treatment have been reported for any of the 16 boys treated to date.

In each cohort, including the final cohort of 20 mg/kg, data for the clinical effects of the treatment will be collected for 26 weeks from first dose.

The open label dose-finding clinical trial is evaluating the systemic delivery of AVI-4658 once per week for 12 weeks by intravenous infusion. Although the study is primarily a safety trial, it includes measures of drug efficacy and pharmacokinetics and is being conducted 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 by Professor Kate Bushby at the Royal Victoria Infirmary, Newcastle-Upon-Tyne, UK, which is the coordinating center for the European Treat Neuromuscular Diseases (Treat-NMD) initiative. The clinical costs for the trial are provided, in part, by the UK Medical Research Council.

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