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16067FW: NATAP: New Antisense HCV Drug AVI-4065 in Trial

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  • alleypat
    Jan 31, 2006
      AVI BioPharma Announces Hepatitis C Virus License Agreement with Chiron

      1/27/2006 9:00:00 AM EST

      AVI BioPharma, Inc. (Nasdaq:AVII), today announced that it has entered into
      an agreement with Chiron Corp. granting AVI a nonexclusive license to
      Chiron's patents and patent applications for the research, development and
      commercialization of antisense therapeutics against hepatitis C virus (HCV).
      Chiron scientists were the first to clone HCV, and the company has been
      granted more than 100 HCV-related patents.

      The license further strengthens AVI's patent position on its HCV antisense
      product candidates, which are already covered by issued U.S. patent claims.
      AVI's lead NEUGENE(R) antisense compound for HCV, AVI-4065, is currently
      being evaluated in a multicenter exploratory safety and efficacy clinical
      trial in the U.S. In conjunction with the license agreement, AVI will issue
      Chiron shares of AVI common stock as an initial license fee payment. Other
      financial terms of the agreement were not disclosed.

      "This agreement with Chiron positions AVI to move forward in our HCV
      development program with confidence and clarity around intellectual
      property," said Denis R. Burger, Ph.D., chief executive officer of AVI. "The
      addition of the HCV patents licensed from Chiron to AVI's own patents
      provides a solid proprietary base in the HCV field for AVI and our eventual
      commercial partners."

      The multicenter clinical study currently underway is designed to assess the
      safety, tolerability, pharmacokinetics and viral response to daily
      subcutaneous administration of AVI-4065 among healthy volunteers and
      patients with chronic active HCV. AVI recently reported completion of the
      first phase of this study with favorable safety, tolerability and
      pharmacokinetic profiles and is now in the second efficacy phase of the
      program. Additional data are expected from this trial later in the first

      The principal investigator of the clinical trial is Mark Holodniy, M.D.,
      F.A.C.P., professor of medicine at Stanford University School of Medicine
      and director of the Department of Veterans Affairs Public Health Research &
      Consultation Program.

      About Hepatitis C

      Chronic HCV infection causes an inflammation of the liver that can result in
      the development of cirrhosis, liver cancer or liver failure. According to
      the World Health Organization, approximately 170 million people worldwide
      are chronically infected with HCV. It is the most common chronic blood-borne
      infection in the developed world and the leading cause of liver transplants
      in the U.S. The CDC estimates that approximately 3.9 million Americans have
      been infected with HCV, of whom 2.7 million are chronically infected.

      The Hepatitis Foundation International estimates that between 8,000 and
      10,000 people die annually in the U.S. from HCV-related cirrhosis or liver
      cancer. The current treatment for HCV, 24 to 48 weeks of therapy with
      pegylated interferon alpha and ribavirin, is successful in less than half of
      the patients infected with genotype 1 HCV, the most common form of the virus
      in the U.S. Furthermore, this treatment has numerous side effects, some of
      them severe, which makes it difficult for almost half of initially treated
      patients to tolerate the recommended dosages and duration of treatment.

      About AVI BioPharma

      AVI BioPharma develops therapeutic products for the treatment of
      life-threatening diseases using third-generation NEUGENE antisense drugs.
      AVI's lead NEUGENE antisense compound is designed to target cell
      proliferation disorders, including cardiovascular restenosis, cancer and
      polycystic kidney disease. In addition to targeting specific genes in the
      body, AVI's antiviral program uses NEUGENE antisense compounds to combat
      disease by targeting single-stranded RNA viruses, including West Nile virus,
      hepatitis C virus, dengue virus and Ebola virus. AVI has introduced a
      NEUGENE-based exon-skipping technology called ESPRIT therapy. More
      information about AVI is available on the company's Web site at

      "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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