AVI BioPharma Inc. Antisense Study Demonstrates Reduction in Angioplasty-Induced Restenosis.

Health/Medical Writers

PORTLAND, Ore.--(BW HealthWire)--Jan. 31, 2001

AVI BioPharma (Nasdaq:AVII, AVIIW, AVIIZ) presented data on the Company's antisense compound, Resten-NG(TM) at a medical conference in Geneva, Switzerland this week.

The data showed that Resten-NG prevented balloon-induced restenosis in advanced preclinical models of restenosis in stented coronary arteries in pigs. The pig animal model is valuable because its coronary artery is similar to human arteries.

Data from the collaborative studies showed that Resten-NG was effective alone and in combination with stents. It was presented at the 7th Local Drug Delivery Meeting and Cardiovascular Conference on Radiation and Molecular Strategies.

The collaborative studies conducted by Patrick L. Iversen, Ph.D., AVI's Senior Vice President of Research and Development, and Nicholas Kipshidze, M.D., of Lenox Hill Hospital, New York, involved catheter delivery of Resten-NG, a proprietary NeuGene(R) antisense compound designed to inhibit restenosis. The hospital is currently one of the study sites for AVI's Phase II human clinical trials of Resten-NG in restenosis.

Dr. Iversen stated, "This study was a rigorous challenge for Resten-NG. It demonstrated highly significant preservation of vessel passageways and prevention of wall thickening following catheter delivery of Resten-NG into stented vessels. These observations build upon previous animal studies of Resten-NG's efficacy conducted at Columbia University and the University of Nebraska Medical Center by outside collaborators, researchers from Lenox Hill Hospital, and AVI scientists."

AVI's CEO Denis R. Burger, Ph.D., said, "It is exciting to see that Resten-NG is continuing to show efficacy in a variety of animal models. With this promising data in hand, our goal is to expand our ongoing Phase II Resten-NG trials to additional medical centers for other applications."

When a patient has a blocked coronary artery, a procedure called balloon angioplasty is frequently used to remove the blockage. During this process, smooth muscle cells underlying the blockage may be damaged, resulting in a proliferative wound healing reaction, which can lead to closure of the artery for a second time.

Restenosis occurs following approximately 20 percent to 40 percent of such procedures, even when stents are employed, and cannot be predicted from patient to patient. Although there are a few new clinical approaches that attempt to prevent restenosis, none is very effective, and all have significant risks associated with them. Approximately 1.8 million balloon angioplasty procedures are performed each year worldwide with a market estimated to exceed $2 billion annually.

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 conducting 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 c-myc. It is currently in Phase II trials for restenosis. More information about AVI is available on the Company's website 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 pre-clinical 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.