AVI BioPharma's results favorable for hepatitis C study

By Lisa Kerner

Erie, Pa., Jan. 10 - AVI BioPharma, Inc. reported positive safety and pharmacokinetic results from the first phase of its clinical trial for chronic active hepatitis C virus.

The multicenter study assessed the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI BioPharma's Neugene (antisense compound AVI-4065).

"There is a large, unmet medical need for effective HCV [hepatitis C virus] treatments, as the current therapy 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.," AVI BioPharma chief executive officer Denis R. Burger said in a company news release.

Current treatment regimens using interferon and ribavirin are expensive, have many side affects and are not well tolerated by many patients, according to the release.

The first phase of the study enrolled and evaluated approximately 30 healthy volunteers at three dosage levels of AVI-4065 (50 mg, 100 mg, 300 mg). Trial participants received subcutaneous injections daily for 14 days.

No serious drug-related adverse events occurred at any dosage level. All dosages were well-tolerated with no injection site reactions or events that required intervention. The target dosage for efficacy phase of this trial will fall between the 100 mg and 300 mg dosages, said the company.

An additional supporting safety and pharmacokinetic study has been completed in nonhuman primates. Groups of primates received daily injections of up to 40 mg/kg AVI-4065 for 28 days or about 15 times the largest human dose used, and for twice the duration. No serious adverse events, toxicities or tolerability issues were observed.

The primate data, along with calculations from the first phase of the clinical study, will provide the basis for a dosage regimen for the second efficacy phase. The second phase will include up to 40 patients with chronic active HCV. Preliminary data from the second phase are expected in the first quarter of this year.

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. The Centers for Disease Control estimates that approximately 3.9 million Americans have been infected with HCV.

AVI BioPharma develops therapeutic products for the treatment of cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. The company is based in Portland, Ore.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.