Clinical Trial Supports Further Study of AVI's NEUGENE Antisense In Polycystic Kidney Disease Patients.

Business Editors, Health/Medical Writers

PORTLAND, Ore.--(BUSINESS WIRE)--Nov. 20, 2002

AVI BioPharma, Inc. (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) today announced that its NEUGENE(R) antisense drug (AVI-4126) proved safe in adult patients with autosomal dominant Polycystic Kidney Disease (PKD).

The Phase 1b clinical trial represented the first time NEUGENES had been given to adult patients with substantial impairment of kidney function, which is important for drug clearance and metabolism.

The single-center study, performed at Legacy Good Samaritan Hospital in Portland, Oregon, showed that significant renal impairment in trial participants did not substantially impact how patients distributed and cleared NEUGENES from the body. This supports the use of NEUGENES as a potential safe and effective treatment for the disease.

"This represents an important milestone in our NEUGENE PKD development program," said David H. Mason Jr., M.D., senior vice president of clinical development and regulatory affairs for AVI. "The information obtained by treating these patients is crucial for designing Phase II studies to test the effectiveness and further define the safety profile of our lead NEUGENE compound for yet another indication."

In this clinical trial, three groups of eight patients with PKD and various degrees of kidney function impairment were exposed to increasing doses of AVI's proprietary NEUGENE antisense drug. The primary purpose of the study was to compare the way the drug is distributed in, and cleared from, the blood in PKD patients compared to normal healthy volunteers. A second important objective was to determine the safety of this drug in this clinical setting.

Side effects were noted as minimal and not related to the study drug. In addition, kidney function was not adversely affected. Further, blood distribution in patients was not significantly different from that of normal volunteers.

"The safety profile of AVI-4126 is excellent, and the blood level, drug distribution and clearance data indicate that we should easily be able to develop a dosing strategy for future drug effectiveness studies," said William Bennett, M.D., director of Transplantation Medicine at Legacy Good Samaritan Hospital, and principal investigator for the Phase Ib trial. "We hope to meet with AVI very soon to discuss plans for further development of this drug in PKD patients."

PKD is the most common human genetic disease, occurring in approximately one in 1,000 births, with an estimated 500,000 Americans suffering from the disease. There are currently no approved or effective medical treatments for PKD.

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 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(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. 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/.

"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.