AVI Initiates Clinical Study to Evaluate the Oral Efficacy of Its NeuGene Antisense Drug
PORTLAND, Ore. - Oct. 10, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII), today announced the initiation of a Phase I study of oral dosing of its NeuGene® antisense drug, AVI-4557, that targets the metabolic enzyme cytochrome P450 3A4. Cytochrome P450 is a liver enzyme responsible for the metabolism of approximately half of currently marketed drugs.
"Oral administration in humans should broaden our therapeutic pipeline, allowing for greater opportunities to partner our drugs with other orally administered drugs that are metabolized by the P450 enzyme," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "Using AVI-4557 to slow the body's metabolism of certain highly toxic drugs may allow for reduced dosing levels of those drugs, thereby potentially limiting toxicity without compromising efficacy."
AVI-4557 has been shown in previous human studies to inhibit the metabolism of two FDA-approved drugs metabolized by P450, the anti-anxiety agent buspirone and the anesthetic midazolam. AVI-4557 has demonstrated activity when administered either by intravenous (IV) or subcutaneous (SC) routes. Previous work with the drug in animal models has indicated that NeuGenes can be absorbed when given orally and effectively inhibit their target.
In the trial, healthy male subjects will be given AVI-4557 in specially designed capsules that open in the small intestine. As in previous IV and SC studies, subjects will be given a test drug, midazolam, before and after dosing with AVI-4557, so that drug effectiveness can be established. Blood levels of AVI-4557 also will be determined and compared with those achieved with other routes of administration.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene antisense drugs and cancer immunotherapy. AVI's lead NeuGene antisense compound is designed to target cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus and hepatitis C. AVI's second technology, Avicine®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic and colorectal cancer. 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 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.