AVI BioPharma Completes NEUGENE Antisense Clinical Trial In Patients With Polycystic Kidney Disease.

Business Editors & Health/Medical Writers

PORTLAND, Ore.--(BW HealthWire)--Aug. 1, 2002

AVI BioPharma, Inc. (Nasdaq:AVII) (Nasdaq:AVIIW) (Nasdaq:AVIIZ), today announced the successful completion of a Phase Ib clinical trial of its NEUGENE(R) antisense drug (AVI-4126) in patients with Polycystic Kidney Disease (PKD).

AVI-4126 targets the expression of c-myc, a gene involved in cell proliferation disorders such as cardiovascular disease, PKD and cancer. Extensive preclinical studies conducted by AVI with its NEUGENE antisense drug in models of PKD demonstrated effectiveness in decreasing the number and size of kidney cysts.

In this Phase Ib study, three groups of patients with PKD and varying degrees of kidney function were exposed to dose escalation studies with AVI-4126. The purpose of the study was to compare the way AVI's NEUGENE antisense drug is distributed in and cleared from the blood in PKD patients compared to normal, healthy volunteers. No serious adverse experiences were seen in this trial, nor was kidney function adversely affected in any patient. Blood levels and clearance data were calculated and will provide guidance for dosing in future studies of drug effectiveness in this disease.

PKD is the most common human genetic disease, occurring in approximately 1 in 1,000 births, with an estimated 500,000 Americans suffering from the disease. PKD is characterized by the formation of cysts in the kidneys and other organs, including the liver and the pancreas. The AVI clinical trial is in the genetic form of PKD referred to as autosomal dominant, which usually becomes clinically apparent in young to middle-aged adults. There are currently no approved or effective medical treatments for PKD.

"We are pleased to announce this major milestone for AVI," said David H. Mason Jr., M.D., senior vice president of clinical development and regulatory affairs for AVI. "Most if not all PKD patients progress to dialysis or kidney transplantation. If we are successful, patients could potentially be spared these difficult outcomes, and cost to the healthcare system could be substantially reduced."

AVI BioPharma will soon convene a group of PKD experts to design the next clinical trial under the guidance of the principal investigator for this trial, William Bennett, M.D., Director of Transplantation Medicine at Legacy Good Samaritan Hospital in Portland, Ore. That trial will investigate the efficacy and safety of AVI-4126 in patients with PKD. This will be a novel trial for this indication, as few if any products have ever been tested in this disease.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NEUGENE(R) 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 recently completed a Phase I NEUGENE antisense study that successfully down-regulated the liver enzyme Cytochrome P450 and modified drug metabolism. 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.