AVI BioPharma Files IND With FDA For West Nile Virus NEUGENE Antisense Drug.

Business Editors/Health/Medical Writers

PORTLAND, Ore.--(BUSINESS WIRE)--June 30, 2003

AVI BioPharma, Inc. (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ), today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its West Nile virus NEUGENE(R) antisense drug, AVI-4020.

The IND application provides the FDA with preclinical, safety and manufacturing data supporting clinical evaluation of a new drug in human patients. The IND filing, if approved, lays the groundwork for AVI to initiate a Phase I clinical trial with its NEUGENE drug in West Nile virus patients this summer.

"We are ready to begin clinical trials of our NEUGENE West Nile drug as soon as the FDA approves the IND," said Denis R. Burger, Ph.D., chief executive officer at AVI. "The robust preclinical results we have produced with AVI-4020, combined with strong safety data from previous NEUGENE antisense clinical trials, and the fact that there are no treatments for West Nile virus currently available, all build a strong case for AVI to begin clinical testing as soon as possible."

The antisense approach to drug discovery serves as a model for the increasingly necessary rapid development of drugs to combat emerging infectious diseases. In the case of the West Nile virus, AVI identified a drug candidate, synthesized and manufactured the compound, completed preclinical testing, and submitted an IND in only eight months. This rapid discovery-to-development program is substantially faster than most drug development efforts.

In developing and testing AVI-4020 against West Nile virus and in preparing its clinical protocol, AVI collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) and with Dr. Richard Whitley, the Project Director of NIAID's Collaborative Antiviral Study Group (CASG). Dr. Whitley will serve as the principal investigator for the clinical trial.

In 2002, the Centers for Disease Control and Prevention recorded 4,156 cases of West Nile virus infection, resulting in 284 deaths. Most people who become infected with WNV have no symptoms, though about 20 percent develop mild, flu-like symptoms, including fever, headache, body aches, and occasionally a rash and swollen lymph glands.

In its most serious manifestations, West Nile virus infection may cause life-threatening inflammation of the brain (encephalitis) or inflammation of the membrane surrounding the brain and spinal cord (meningitis), as well as a number of other significant neurologic symptoms, including muscle paralysis similar to that seen with poliovirus infections and others that mimic the symptoms of Parkinson's disease.

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(R), a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and pancreatic cancer, and the company plans to initiate a Phase III pivotal trial in pancreatic cancer, with a supporting study in colorectal cancer. The first application of its NEUGENE compounds, Resten-NG(TM), 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. The company is currently in a Phase II trial for restenosis. AVI has completed four Phase I NEUGENE antisense studies that successfully down-regulated the liver enzyme cytochrome P-450 and modified drug metabolism, a Phase Ib trial in polycystic kidney disease, and a Phase Ib trial in cancer. More information about AVI is available on the Company's Web site 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 preclinical 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.