AVI BioPharma Announces FDA Clearance of IND Applications for Clinical Trials of RNA Therapeutic Agents for Treatment of Ebola a
December 23 2008 - 4:22PM
Marketwired
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.
"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 company's Securities and Exchange
Commission filings.
AVI Press and Investor Contact: Julie Rathbun
investorrelations@avibio.com (541) 224-2575
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