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AVI BioPharma Expands Clinical Pipeline With Initiation of Phase 1 Study of Influenza Therapeutic Candidate

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AVI BioPharma, Inc., a developer of RNA-based therapeutics, has announced that it initiated dosing of volunteers in a Phase 1 clinical study of AVI-7100, the Company's lead drug candidate for the treatment of influenza.

AVI-7100 is a therapeutic candidate with a novel mechanism of action and potentially broad-spectrum activity against influenza viruses, including Tamiflu-resistant virus strains. This clinical trial is the third Phase 1 program initiated this year for an AVI infectious disease drug candidate.

In the randomized, double-blind, placebo-controlled study, AVI will assess the safety, tolerability and pharmacokinetics of AVI-7100 administered via intravenous infusion in single-ascending doses in up to 48 healthy adult volunteers.

The study will have six cohorts consisting of six volunteers who receive the therapeutic and two who will receive a placebo.

"AVI-7100 offers a promising, novel approach with potential broad-spectrum activity for the treatment of influenza," said Chris Garabedian, AVI's President and CEO.

"This is especially important because of the decrease in utility of current flu therapies in light of the increase of drug-resistant strains of the virus. To support the continued development of the AVI-7100 influenza program and our mission of advancing innovative treatment options, we will respond to an RFP announced in May by the U.S. Department of Defense seeking the full clinical development of influenza therapeutics for both prophylaxis and treatment."