AVI BioPharma Submits IND for NeuGene Antisense Drug Targeting Hepatitis C Virus
PORTLAND, Ore. — June 30, 2005 — AVI BioPharma, Inc. (Nasdaq: AVII), 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 www.avibio.com.
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