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AVI BioPharma to Present Safety Update From Ongoing Systemic Trial of AVI-4658 at 7th Annual Action Duchenne International Conference

Posted on 25 October 2009 - 13:57 by Alfie

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Story Summary: 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 slow intra-venous 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 and at the Royal Victoria Infirmary, Newcastle-Upon-Tyne, UK, which is the coordinating center for the European Treat Neuromuscular Diseases (Treat-NMD) initiative. About Duchenne Muscular Dystrophy (DMD)DMD is one of the most common fatal genetic disorders to affect children around the world. Approximately one in every 3,500 boys worldwide is afflicted with Duchenne Muscular Dystrophy with 20,000 new cases reported each year. Progressive muscle weakness of the legs and pelvis eventually spreads to the arms, neck, and other areas. By age 10, braces may be required for walking, and most patients are confined to a wheelchair by age 12. Eventually, this progresses to complete paralysis and increasing difficulty in breathing requiring ventilatory support. Unlike other RNA therapeutic approaches, AVIs antisense technology has been used to directly target both messenger RNA (mRNA) and its precursor (pre-mRNA), allowing for both up- and down-regulation of targeted genes and proteins. AVIs RNA-based drug programs are being evaluated for the treatment of Duchenne muscular dystrophy as well as for the treatment of cardiovascular restenosis through our partner Global Therapeutics, a Cook Group Company. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the companys Securities and Exchange Commission filings….Read the Full Story

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