AVI BioPharma Scientist Presents Data Showing Novel Antisense Inhibits Gene Expression of Metabolic Enzyme in Human Live
PORTLAND, Ore. - March 13, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ) today announced that scientist Vikram Arora, Ph.D., has presented new research data showing that AVI's proprietary NeuGene® antisense technology can be used to decrease metabolism of paclitaxel, reduce its clearance in the liver and thereby increase bioavailability using smaller doses of the drug. Dr. Arora presented the data at the 42nd annual meeting of the Society of Toxicology in Salt Lake City.
Dr. Arora's study demonstrated that AVI's NeuGene antisense technology (AVI-4557) is an effective and specific inhibitor of the rat liver enzyme CYP3A2 when paclitaxel is used as a test drug. The trial, conducted in rats, replicates similar results AVI has achieved in human clinical trials targeting the human liver enzyme CYP3A2, administered with other test drugs including BuSpar and Midazolam, both preanesthetics.
In the experiment, the drug was injected intraperitoneally into male rats at a 2.5 mg/kg/day dose for three days. AVI-4557 was administered 48 hours before paclitaxel, which was administered as a single bolus intravenous injection at the dose of 8 mg/kg.
Antisense pretreatment resulted in sequence-specific decrease in CYP3A2 activity and statistically significant alteration in pharmacokinetic parameters of the paclitaxel.
"We conducted this study to show that our AVI-4557 antisense can be used to alter the pharmacokinetics of paclitaxel, a highly toxic chemotherapy drug," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "Combined with the results of our recent drug metabolism studies in humans, this data suggests that paclitaxel doses could be decreased when delivered following AVI-4557 administration. This approach would limit toxicity without compromising efficacy of the chemotherapy."
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 a Phase Ib 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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