SOURCE: AVI BioPharma, Inc.
December 23, 2008 16:23 ET
AVI BioPharma Announces FDA Clearance of IND Applications for Clinical Trials of RNA Therapeutic Agents for Treatment of Ebola and Marburg Viruses
PORTLAND, OR--(Marketwire - December 23, 2008) - AVI BioPharma, Inc. (NASDAQ: AVII), a
developer of RNA-based drugs, announced that it learned earlier today 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 viruses.
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-6003 demonstrated reproducible and
high rates of survival in non-human primates challenged with a lethal
infection of the Ebola and Marburg viruses.
About AVI BioPharma
AVI BioPharma is focused on the discovery and development of RNA-based
drugs utilizing proprietary derivatives of its antisense chemistry
(morpholino-modified phosphorodiamidate oligomers or PMOs) that can be
applied to a wide range of diseases and genetic disorders through several
distinct mechanisms of action. Unlike other RNA therapeutic approaches,
AVI's 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. AVI's 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. AVI's antiviral
programs have demonstrated promising outcomes in Ebola Zaire and Marburg
Musoke virus infections and may prove applicable to other viral targets
such as HCV or Dengue viruses. For more information, visit www.avibio.com.
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