AVI BioPharma, Inc. Completes Patient Enrollment of AvicineTM Phase II Clinical Trial in Pancreatic Cancer.

Business Editors Health/Medical Writers

PORTLAND, Ore.--(BUSINESS WIRE)--Nov. 14, 2000

AVI BioPharma, Inc. (Nasdaq:AVII, AVIIW, AVIIZ) today announced that it has completed patient enrollment in its multicenter Phase II clinical trial of the company's therapeutic cancer vaccine, Avicine, in pancreatic cancer patients.

The randomized trial, involving 50 patients, was conducted at seven centers nationwide and was designed to evaluate the safety and efficacy of Avicine alone versus the potential synergistic effects of Avicine in combination with Eli Lilly & Co.'s (NYSE:LLY) chemotherapy drug, gemcitabine (GemzarTM).

This trial marks two advances in AVI's Avicine development strategy. The study included a new Avicine formulation containing an additional peptide domain, which the company believes may enhance the effectiveness of the vaccine. Moreover, this study marks the first trial in which the vaccine was administered in combination with a chemotherapeutic agent. John Marshall, M.D. of Georgetown University served as principal investigator for the study, which was managed by Premier Research Worldwide, a clinical research organization.

[pilcrow (paragraph sign)] This trial followed Phase Ib/II clinical trials of Avicine, which were designed to evaluate safety and efficacy in pancreatic cancer patients. The evidence from these studies suggested that Avicine showed clinical promise and was well-tolerated without systemic toxicity.

Denis Burger, Ph.D., CEO of AVI BioPharma, stated, "The completion of patient enrollment in this Phase II trial of Avicine in pancreatic cancer represents a significant milestone for the company, and is the result of extensive clinical efforts to demonstrate the applicability of our vaccine technology to a broad range of cancers. Because pancreatic cancer is so aggressive, the combination of Avicine and a chemotherapeutic agent may provide additional benefits beyond either therapy alone." Dr. Marshall stated, "We have been impressed with the Avicine data from AVI's Phase II study in colorectal cancer where statistically significant survival benefits correlated with an antibody response. As a result, we have been very pleased to be involved in this study, especially since Avicine appears to work through a unique mechanism, distinctly different from chemotherapy. Given the vaccine's excellent safety profile and lack of systemic toxicity, we are encouraged that Avicine alone may provide survival benefits over chemotherapy. Additionally, the evaluation of Avicine plus gemcitabine may also provide evidence for the inclusion of the vaccine in combination therapy."

Cancer of the pancreas is the fifth leading cause of cancer death in the United States. This year an estimated 28,000 people in the United States will die from this disease. Currently, fewer than 10 percent of patients live more than one year after diagnosis and fewer than 50 percent will survive six months.

Avicine, a therapeutic cancer vaccine, is AVI BioPharma's lead product candidate. Avicine elicits a highly specific immune response to the human hormone and growth factor hCG, a cancer-associated oncofetal protein. Avicine is essentially a non-toxic immunotherapy and has been evaluated in five clinical trials. To date, more than 250 patients have been treated. Early studies have provided evidence of objective tumor responses and apparent survival benefits in patients who have failed conventional therapy. AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, Avicine, will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in prostate cancer. The first application of its NeuGene compounds, Resten-NG, 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 cardiovascular restenosis. More information about AVI is available 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 pre-clinical 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.