AVI BioPharma Submits IND for NEUGENE Antisense Drug Targeting Hepatitis C
Virus
Thursday June 30, 9:00 am ET


PORTLAND, Ore.--(BUSINESS WIRE)--June 30, 2005--AVI BioPharma, Inc.
(Nasdaq:AVII
- News), today announced that it has submitted an Investigational New Drug
(IND)
application with the U.S. Food and Drug Administration (FDA) for its
NEUGENE®
antisense drug AVI-4065 targeting hepatitis C virus (HCV). The application
provides the FDA with preclinical safety, toxicology and manufacturing data
in
support of clinical evaluation of AVI-4065 in humans who are chronically
infected with HCV.

"With a response rate of less than 50 percent for patients receiving
existing
treatments for the most common type of HCV infection, there remains a large
unmet medical need for new and effective treatments," said Denis R. Burger,
Ph.D., chief executive officer at AVI. "Our previous work in other viral
research, including West Nile virus, has given us valuable insights on
dosing,
administration and pharmacokinetic data with which to begin this clinical
program. That data, combined with the strong safety results we have seen in
over
250 patients treated with NEUGENE drugs to date, greatly increases our
confidence in the potential success of AVI-4065 for treating HCV."
As proposed in the IND application, the initial multicenter Phase IB
clinical
trial will include up to 50 patients in three treatment groups: normal
subjects
and two groups of patients with chronic, active HCV, including patients who
are
newly diagnosed, and those who have failed the current standard of care,
which
is interferon and ribavirin. The study will assess the safety, tolerability,
pharmacokinetics and viral response to daily subcutaneous administration of
AVI-4065 at two dosage levels for a specific period of time.

Mark Holodniy, M.D., F.A.C.P., C.I.C., associate professor of medicine at
Stanford University School of Medicine and director of the HIV Clinical
Program
and AIDS Research Center at Veterans Affairs Medical Center in Palo Alto,
Calif., will serve as the principal investigator for this intended
multicenter
study.

HCV is a single-stranded RNA virus known to undergo a high rate of mutation,
which may help the virus develop resistance to many current and
development-stage antiviral medications. Because HCV and other
single-stranded
RNA viruses have relatively simple genetic structures, they are attractive
targets for AVI's NEUGENE antisense, which is designed to target conserved
portions of the viral genetic code that are not likely to mutate over time,
after drug exposure.

Another NEUGENE drug, AVI-4020, is currently being studied in a clinical
trial
of patients exhibiting presumptive neuroinvasive disease caused by West Nile
virus. In addition, NEUGENE drugs are being tested against a variety of
hemorrhagic, infectious and toxin-producing agents in collaboration with the
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the
Walter Reed Army Institute of Research (WRAIR), and the Centers for Disease
Control and Prevention (CDC).

About Hepatitis C

Hepatitis C infection is an inflammation of the liver caused by the
hepatitis C
virus. 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 United States. 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 United States from
HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to
48
weeks of therapy with PEG-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. In addition, this treatment has numerous side effects,
some of them severe, which make it difficult for many 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 and cancer. 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.
More information about AVI is available on the company's Web site at
http://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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Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
hubbard@...
or
Lippert/Heilshorn & Associates Inc.
Investor Contacts
Bruce Voss, 310-691-7100
bvoss@...
or
Jody Cain, 310-691-7100
jcain@...
or
Waggener Edstrom Bioscience
Press Contact
Wendy Carhart, 503-443-7000
wendyc@...