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Study Shows Stents Coated with AVI BioPharma's Antisense Compound Reduces Coronary Restenosis.


Business Editors & Health/Medical Writers

PORTLAND, Ore.--(BUSINESS WIRE)--Nov. 14, 2001

The study also compared AVI's antisense coated stents to

paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , dactinomycin dactinomycin /dac·ti·no·my·cin/ (dak?ti-no-mi´sin) actinomycin D, an antibiotic derived from several species of Streptomyces; used as an antineoplastic.

dac·ti·no·my·cin
n.
, and sirolimus coated stents.

AVI BioPharma, Inc. (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) demonstrated that stents coated with its proprietary NeuGene(R) antisense compound, Resten-NG (AVI-4126), significantly reduced coronary restenosis.

The preclinical study results, presented at the American Heart Association's annual scientific session November 11-14, also compared AVI-4126 to three other compounds currently in clinical trials.

The data showed arteries treated with AVI-4126-coated stents healed almost as quickly as those treated with uncoated stents. Arteries treated with stents coated with dactinomycin (Cosmegen(R) or actinomycin-D) and paclitaxel (Taxol(R)) healed much more slowly. No significant difference in healing time with sirolimus (Rapamune(R)) was detected. In addition, unlike these three comparison drugs, AVI-4126 is not cytotoxic.

"Longer healing times expose the artery to greater risks, such as thinned vessel walls that could lead to an increase in aneurysms and stroke, or an increase in blood clot formation," said Patrick L. Iversen, Ph.D., AVI's Senior Vice President of Research and Development. "This study showed AVI-4126 does not increase these risks. Coupled with data from recently completed clinical trials that shows NeuGenes are free from significant side effects, we're excited about what the future holds for this technology platform."

Through an agreement announced in May, AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples.  and Medtronic, Inc (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) are developing a coated stent using NeuGene antisense technology described in this study. Medtronic was the first company to introduce coated stents, starting in the 1990s.

"Results like these are what led us to the agreement with Medtronic, and serve to strengthen our business goals in this area," said Denis Denis, king of Portugal: see Diniz.  R. Burger, Ph.D., AVI's Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We expect to be using the Resten-NG coated stents in Phase III human trials next year."

Nicholas Kipshidze, Ph.D., M.D., a scientist at the Lenox Hill Heart & Vascular Institute in New York, NY, presented the findings and was principal investigator for the study. AVI-4126 targets the c-myc gene and is designed to inhibit the events associated with activation of the proteins that led to cardiovascular restenosis. The study was successful in showing reduced activity of the c-myc gene.

Resten-NG is also being evaluated for prevention of restenosis by catheter delivery in ongoing Phase II clinical trials.

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, AVICINE(TM), a therapeutic cancer vaccine, has completed enrollment in a Phase II trial in pancreatic cancer, and is in a Phase III pivotal trial 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 oncogene

Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells.
 c-myc. It is currently in a Phase II trial for restenosis and a Phase I/II study for cancer. The Company's antisense compound that targets the liver enzyme CYP CYP

In currencies, this is the abbreviation for the Cyprus Pound.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
450 3a4 is currently in a Phase I trial. More information about AVI is available at http://www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 pre-clinical and clinical testing, the effect of regulation by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Companies' Securities and Exchange Commission filings.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Nov 14, 2001
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