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