Rodman & Renshaw / AVII / Updated Safety Results for AVI-4658 in DMD - Final 20 mg/kg Cohort Enrolling

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Solid Safety Profile Upheld In Latest Update Yesterday, AVI BioPharma presented updated data on the company's ongoing, open-label, systemic Phase 1b/2 trial of AVI-4658 for the treatment of Duchenne muscular dystrophy (DMD) at the TREAT-NMD / NIH International Conference taking place November 17-19 in Brussels, Belgium. The most recent safety data demonstrate that AVI-4658 has been well tolerated in a dose escalation study that is now enrolling the sixth and final cohort at 20 mg/kg. The maximum cumulative dose administered to date has been updated to 3132 mg, with a maximum single dose reaching 900 mg, with no adverse safety signals in either circumstance. By way of reference, results presented at the 7th Annual Action Duchenne Conference in October 2009, highlighted that the maximum cumulative dose reached was 2797 mg and the maximum single dose reached was 300 mg, with no safety signals or significant side effects arising in any of the 16 boys treated. Of note, at the TREAT-NMD / NIH meeting, pre-clinical data was also presented demonstrating that treatment with AVI-4658 was tolerated at dosages up to 960 mg/kg in mice and up to 320 mg/kg in primates, both doses which are feasible in human subjects.