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AVI BioPharma Announces FDA Clearance of IND Applications for Clinical Trials of RNA Therapeutic Agents
AVI BioPharma, Inc. has announced that it has received verbal clearance from the United States Food and Drug Administration (FDA) for the Investigational New Drug (IND) applications filed in November for its two lead products for Marburg and Ebola virus. AVI BioPharma expects to receive written confirmation of the IND clearances from the FDA in early 2009.
AVI–6002 and AVI–6003 are novel analogs based on AVI’s PMO antisense chemistry in which anti–viral potency is enhanced by the addition of positively–charged components to the morpholino oligomer linkage.
Preclinical results of AVI–6002 and AVI–6033 demonstrated reproducible and high rates of survival in non–human primates challenged with a lethal infection of the Ebola and Marburg viruses.
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