Studies Support Targeted Systemic Delivery of NeuGene Antisense To Treat Coronary Arteries
PORTLAND, Ore. - Nov. 19, 2002 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced the results of two independent studies that demonstrate the feasibility of treating cardiovascular restenosis without the use of special drug delivery catheters or drug-coated stents. These preclinical studies used the company's proprietary microbubble delivery technology to deliver AVI's NeuGene® antisense drug, Resten-NG™, to balloon injured coronary arteries.
The results of the two separate studies were reported at the annual American Heart Association meetings this week in Chicago by Nicholas Kipshidze, M.D., Ph.D., of the Lenox Hill Heart and Vascular Institute and Thomas Porter, M.D., of the University of Nebraska Medical Center.
Resten-NG is effective in reducing coronary occlusion following balloon angioplasty in multiple animal models and has shown favorable data from interim analysis in a phase II human study. Resten-NG targets and blocks c-myc, a gene that regulates cell proliferation and is the key factor in the cascade of effects that lead to restenosis in many angioplasty patients.
Previous AVI studies employed local delivery catheters and coated stents to deposit Resten-NG into injured coronary vessels. The additional delivery approach utilizes perfluorocarbon gas microbubble carriers (PGMC) to carry Resten-NG to the site of vessel injury and deposit it within the injured region without the use of these delivery devices.
"An intravenous alternative to catheters and coated stents for targeted systemic delivery represents an important advancement in the prevention of restenosis following coronary angioplasty," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "We feel this technology may also offer greater flexibility of repeated dosage regimes, treatment of small vessels, and reduced procedural complexity."
The study conducted by Dr. Kipshidze involved balloon angioplasty and bare stent implantation followed by Resten-NG delivered by PGMC administered intravenously in pigs. Resten-NG was detected in the coronary vessels four hours after delivery and inhibition of c-myc, the target of Resten-NG, was observed. A significant reduction in coronary artery thickening was observed 28 days after the procedure. Further, less inflammation and decreased vessel fibrosis were observed in the treated animals.
A larger study conducted by Dr. Porter similarly observed significant reductions in the vessel wall thickness and in the area of vessel restenosis. Resten-NG was again recovered from the vessel wall, and c-myc expression was reduced after the injections.
"This technology represents an important new delivery method for our NeuGene platform," said Denis R. Burger, Ph.D., AVI's CEO. "The microbubbles increase our flexibility in a variety of clinical settings."
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 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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