AVI BioPharma Files IND Application for Resten-NG with FDA, Leads Way to New Era of Antisense Therapeutics.

PORTLAND, Ore.--(BW HealthWire)--Nov. 16, 1999--

AVI BioPharma (Nasdaq:AVII) (Nasdaq:AVIIW, AVIIZ) today announced that the Company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Resten-NG(TM), its gene-targeted therapeutic drug.

Designed to combat cardiac restenosis, Resten-NG is the first compound from AVI's novel, third generation NeuGene(R), antisense technology platform to enter into clinical trials.

Denis Burger, President and Chief Executive Officer of AVI said, "We're very excited about this IND filing because we believe it heralds a new era in antisense therapeutics. In the late 1980s, AVI chose to redesign antisense chemistry to overcome significant pharmaceutical limitations that are still inherent in other antisense approaches. This filing is the culmination of that decision followed by years of exhaustive research. It positions AVI as a leader in this field.

"AVI's NeuGene drugs have proven to be more efficacious than conventional antisense compounds while exhibiting much lower toxicity profiles," Burger continued. "This means that the therapeutic window, the difference between the dose that produces efficacy and the dose that produces toxicity, is very large. Because NeuGene compounds were designed and synthesized with novel chemistries, they have pharmaceutical advantages not possible with other antisense technologies."

Restenosis, the re-closing of an artery, is a complication that occurs in 20 to 40 percent of patients following a balloon angioplasty procedure to clear blockage in coronary arteries. Immediately following an angioplasty procedure, smooth muscle cells may begin to divide rapidly in some patients, causing closure of the artery for a second time. Each year, approximately 500,000 balloon angioplasty procedures are performed in the United States.

"Preclinical studies of Resten-NG for the treatment of restenosis have shown highly significant preservation of vessel passageways and prevention of arterial wall thickening following delivery of this NeuGene agent," commented Patrick L. Iversen, Ph.D., AVI's Senior Vice President of R&D. "Delivering Resten-NG to the site of angioplasty blocks the growth and proliferation events in the vessel walls that have been cleared by the balloon angioplasty. We believe that the introduction of Resten-NG and future third-generation NeuGene drugs into the clinic may finally fulfill the early promise that other antisense technologies have struggled to meet."

Pending approval of the application, Phase I safety studies of Resten-NG in humans will begin.

AVI BioPharma develops products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, Avicine(TM), an essentially non-toxic cancer vaccine, is in a Phase II trial in pancreatic cancer, and will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in prostate cancer. AVI has also completed preclinical trials for gene-targeted drugs based on its third generation, NeuGene(R), antisense technology. The first applications of AVI's NeuGene technology are designed to treat cardiovascular disease, cancer, and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene c-myc.

Certain statements made in this press release related to efficacy of NeuGene drugs, their pharmaceutical advantages, and the results and success of Resten-NG in patients for cardiac angioplasty, as well as potential start date of clinical trials and results and government approvals, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may differ materially from those set forth in these statements. In addition, the economic, competitive, governmental, technological and other factors identified in the Company's filings with the Securities and Exchange Commission could affect such results.