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AVI BioPharma Announces Hepatitis C Virus Clinical Study Modification.


PORTLAND, Ore. -- AVI BioPharma, Inc. (Nasdaq:AVII) announced today that it has entered patients to fill two new cohorts to extend the duration of treatment with AVI-4065 in its hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
 (HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
) clinical trial. One cohort will be treated twice daily for 28 days and the second will receive therapy twice daily for 56 days. This extension of the treatment duration from 14 days to 28 days and 56 days is the first of several variables that the company is considering.

This extension of duration of treatment is based on pharmacokinetic indications from previous cohorts, including normal subjects and HCV patients, after evaluation of preliminary data released May 2006 at the International Conference on Antiviral Research. It is designed to potentially enhance the pharmacokinetics and viral and clinical response to treatment with AVI's proprietary NEUGENE(R) antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid).  compound, AVI-4065, in patients with HCV.

"Since preclinical models of HCV are rarely predictive of chronic active HCV in patients, we anticipated that some modifications to the protocol might be required to optimize the pharmacokinetics and potential efficacy of the drug," said Denis Denis, king of Portugal: see Diniz.  R. Burger, Ph.D., chief executive officer of AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. . "We are fortunate that the safety profile of our NEUGENE antisense platform easily allows for changes such as this, including potential increases in duration of therapy, dosage modification, combination targeting, and enhanced delivery options. We continue to be pleased with the progress of this program and are actively moving forward. We believe that, just as we did with the development of drug candidates for the Ebola virus after reviewing initial data, we can fine-tune development leading to a viable drug therapy."

In previous studies, AVI-4065 exhibited favorable safety and tolerability profiles in all patients, and there were no drug-related adverse events or tolerability issues reported during either the 14 days of treatment or the 28 days of follow-up. Preliminary data from the first three cohorts of normal subjects were reported in January 2006 and the trial was completed in March 2006. Those cohorts included 31 healthy volunteers who received 14 consecutive days of treatment with AVI-4065 at one of three dosage levels. Clinical and viral response data from the previous cohorts of HCV patients treated for 14 days with AVI-4065 are expected to be reported to be spoken of; to be mentioned, whether favorably or unfavorably.

See also: Report
 by the end of the third quarter of 2006.

HCV is a single-stranded RNA virus. 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. This approach is intended to reduce the opportunity for the virus to evolve resistance to the therapy over time.

About Hepatitis C Virus Infection

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 Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  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 weeks to 48 weeks of therapy with pegylated interferon alpha Pegylated interferon alpha can refer to:
  • Pegylated interferon-alpha-2a
  • Pegylated interferon-alpha-2b
 and ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon , is successful in less than half 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 make it difficult for nearly 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 Polycystic Kidney Disease Definition

Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders.
. 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 hepatitis C virus, influenza A virus, West Nile virus West Nile virus, microorganism and the infection resulting from it, which typically produces no symptoms or a flulike condition. The virus is a flavivirus and is related to a number of viruses that cause encephalitis. , 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 http://www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 20, 2006
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