AVI BioPharma Discloses New Contract With U.S. Government for up to $18 Million to Advance Development of AVI-7100 as H1N1 Flu T
June 07 2010 - 9:45AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based
therapeutics, today filed a current report on Form 8-K with the
U.S. Securities and Exchange Commission providing the following
disclosure:
On June 4, 2010, AVI BioPharma, Inc. (the "Company"), entered
into a new contract with the U.S. Defense Threat Reduction Agency
("DTRA") to advance the development of AVI-7100, which was
previously designated AVI-7367 and which has been renumbered by
AVI, as a medical countermeasure against the pandemic H1N1
influenza virus (swine flu) in cooperation with the
Transformational Medical Technologies program ("TMT") of the U.S.
Department of Defense. The contract provides for funding of up to
$18 million to advance the development of AVI-7100, including
studies enabling an Investigational New Drug (IND) application with
the U.S. Food and Drug Administration, the study of an intranasal
delivery formulation, and the funding of a Phase 1 clinical trial
to obtain human safety data to support potential use under an
Emergency Use Authorization.
AVI-7100 is the Company's lead RNA-based influenza therapeutic
candidate using AVI's proprietary PMOplus™ chemistry. AVI recently
secured additional funding of up to approximately $4.0 million
under an amendment to a separate earlier contract with DTRA to
support, in cooperation with TMT, expanded preclinical evaluation
of AVI-7100 against H1N1, H5N1 (avian flu), and drug resistant H1N1
and H3N2 flu strains.
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,
including an ongoing systemic Phase 1b/2 clinical trial of exon
skipping with AVI-4658. 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
Junín, influenza, 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.
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