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news.Avi BioPharma, a developer of RNA-based drugs, has received verbal clearance from the FDA for the investigational new drug applications filed in November 2008 for its two lead products for Marburg and Ebola viruses.
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AVI-6002 and AVI-6003 are novel analogs based on Avi’s phosphorodiamidate morpholino oligomers antisense chemistry in which anti-viral potency is enhanced by the addition of positively-charged components to the morpholino oligomer linkage. AVI BioPharma expects to receive written confirmation of the investigational new drug (IND) clearances from the FDA in early 2009.
Preclinical results of AVI-6002 and AVI-6003 reportedly demonstrated reproducible and high rates of survival in non-human primates challenged with a lethal infection of the Ebola and Marburg viruses, the company said.