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AVI BioPharma Initiates Hepatitis C Clinical Trial
PORTLAND, Ore.–(BUSINESS WIRE)–Sept. 28, 2005–AVI BioPharma, Inc. (Nasdaq:AVII), today announced the initiation of an exploratory safety and efficacy clinical trial using its proprietary NEUGENE(R) antisense compound AVI-4065. The multicenter study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 among healthy volunteers and patients with chronic active hepatitis C virus (HCV).
“There is a large, unmet medical need for effective HCV treatments, as the current treatment regimen 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.,” said Denis R. Burger, Ph.D., chief executive officer of AVI. “In addition, the de facto treatment regimen of nonspecific antivirals pegylated interferon and ribavirin is expensive, has a plethora of side effects, and is not well tolerated by many patients. The ability of our NEUGENE antisense to specifically target the HCV virus may offer a safer and more efficacious drug for patients.”
The multicenter clinical trial will include 80 subjects: 40 healthy adult volunteers in the first phase of the study and 40 patients with chronic active HCV in the second phase. In the first phase, up to four dosage levels will be evaluated to confirm the safety of desired serum drug levels. In the second phase, 40 patients with chronic active HCV will be enrolled, including patients who are drug-naive and patients who have failed conventional interferon and ribavirin treatment. This phase of the trial will assess the safety, tolerability, pharmacokinetics, biological responses and HCV virological effects of AVI-4065 over a minimum of 14 days of treatment. Patients will be monitored following treatment to assess a sustained HCV virological response to AVI-4065.
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 located at the Veterans Affairs Palo Alto Health Care System in Palo Alto, Calif., will serve as the principal investigator for the trial. Dr. Holodniy said, “I am pleased to participate as an investigator at one of many study sites in the rigorous clinical testing of AVI’s lead compound targeted for the HCV virus. The study should provide a better understanding of the compound’s safety, pharmacokinetics, and potential biological effects against HCV.”
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 that are not likely to mutate over time.
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 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 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 make 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. More information about AVI is available on the company’s Web site at http://www.avibio.com.
