AVI Begins Phase II Study of Systemic Delivery Of Resten-NG in Restenosis
Trial to Incorporate Proprietary Antisense and Microbubble Delivery Technologies
PORTLAND, Ore. - Aug. 19, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII), today announced the initiation of a Phase II clinical study of its antisense drug, Resten-NG®, in patients undergoing angioplasty and stent placement. Resten-NG, the company's flagship cardiovascular NeuGene® antisense agent, works by inhibiting the expression of the c-myc gene, which plays a key role in the development of restenosis. In the study, Resten-NG will be delivered using AVI's proprietary microbubble delivery system.
"Delivering Resten-NG systemically using microbubbles has been as effective as local delivery with stents and catheters in our preclinical tests," said David H. Mason, Jr., M.D., senior vice president of Clinical Development and Regulatory Affairs at AVI. "Our microbubble technology may offer a potential cost-effective supplement, or alternative, to using drug-coated stents. This alternative method may be used even in patients who require placement of multiple stents."
The placebo-controlled study will be conducted at the University of Nebraska Medical Center under the direction of Thomas Porter, M.D., and Edward O'Leary, M.D. Patients undergoing angioplasty and stent placement will be given Resten-NG via intravenous injection of drug-coated microbubbles. In preclinical experiments, the microbubbles have been shown to concentrate at the sites of vascular injury.
"Using microbubbles to deliver Resten-NG complements our other restenosis development programs," said Denis R. Burger, Ph.D., AVI's CEO. "This latest study is further evidence of strides we've made in our antisense drug programs and the strength of our drug development platform. Systemic delivery has the advantage of getting our drug to all sites of vascular injury, rather than just to the sites where a stent is placed. Further, this study may open the door to repeat applications of the drug, if deemed necessary, which is not available with drug delivery via stent."
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene® antisense drugs and cancer immunotherapy. AVI's lead NeuGene antisense compound is designed to target cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus, and hepatitis C. AVI's second technology, Avicine®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic and colorectal cancer. More information about AVI is available on the company's Web site at http://www.avibio.com/.
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