Study Supports Topical Application of AVI's NeuGene® Antisense
PORTLAND, Ore. - Oct. 29, 2002 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced the first evidence that topical application of AVI's antisense drugs can produce systemic changes in gene expression in the liver in vivo through dermal penetration. The results were peer-reviewed and published in the October issue of Pharmaceutical Research, Vol. 19, No. 10.
The study used antisense to down-regulate cytochrome P450 in rats. This key metabolic enzyme is found in the liver and other tissues, including the skin. The study showed that NeuGene® antisense applied topically inhibited the enzyme at three dosage levels, reaching the maximum anticipated inhibition of enzyme activity.
"This study further builds on AVI's ongoing effort to identify and design multiple routes of administration of our NeuGene antisense," said Denis R. Burger, Ph.D., CEO of AVI. "In addition, the results demonstrate the potential use of our antisense to alter gene expression in skin and demonstrate the feasibility of using topical antisense applications to treat both systemic and dermal disease indications."
Topical delivery for antisense therapeutics would be preferable in certain circumstances. Not only would the convenience of topical delivery potentially increase patient compliance, it may also be useful in patients with gastro-intestinal problems which can affect the pharmacokinetics of certain orally administered drugs.
AVI has completed several NeuGene antisense studies targeting cytochrome P450, a key liver enzyme responsible for the metabolic breakdown of approximately 50 percent of current FDA-approved drugs. Most recently, AVI completed a 96-patient study that demonstrated that AVI's antisense successfully down-regulated the liver enzyme using both subcutaneous and intravenous administration.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NeuGene antisense drugs and cancer immunotherapy. Its lead cancer agent, AVICINE®, a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and pancreatic cancer and is initiating a Phase III pivotal trial in pancreatic cancer, with a supporting study in colorectal cancer. The first application of its NeuGene compounds, Resten-NG™, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene c-myc. It is currently in Phase II trials for restenosis and in a Phase I/II trial for cancer. AVI has completed a Phase I NeuGene antisense study that successfully down-regulated the liver enzyme cytochrome P450 and modified drug metabolism, and also recently completed a Phase I/II trial in polycystic kidney disease. More information about AVI is available on the Company's Web site at http://www.avibio.com/.
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