AVI BioPharma Announces Plans to Initiate Phase III Clinical Trial In Pancreatic Cancer With AVICINE; Streamlined Clinical Strategy Could Result in Shorter Time to Approval.

Business Editors, Health/Medical Writers

PORTLAND, Ore.--(BW HealthWire)--May 2, 2002

AVI BioPharma, Inc. (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) today announced that the company plans to initiate a Phase III clinical trial program in pancreatic cancer with its therapeutic cancer vaccine, AVICINE(R).

These plans are based on analysis of the one-year survival data in a recently completed Phase II trial in patients with pancreatic cancer.

The Phase III pancreatic cancer clinical trial design involves three treatment arms of approximately 200 patients each: AVICINE vaccine alone, gemcitabine (Gemzar(R), Eli Lilly & Co., NYSE: LLY) alone, and AVICINE in combination with Gemzar. The primarY endpoints will be median survival and one-year survival. AVI plans to initiate this pivotal trial later in 2002 with its U.S. marketing and co-development partner, SuperGen, Inc.

The Phase III pancreatic trial represents a "streamlining" of the company's AVICINE approval strategy. It couples what the company believes is a shorter-duration pancreatic trial with a revised colorectal cancer protocol, designed to treat later-stage colorectal patients.

"The FDA currently recommends two studies for all new cancer drugs, a pivotal Phase III study and a second Phase II/III supporting study," said Denis R. Burger, Ph.D., chief executive officer of AVI. "By making the pancreatic cancer trial our primary study and shifting the colorectal cancer trial to become our supporting study, we believe that we will have both better defined study endpoints and a shorter time to overall trial completion and approval."

In the recently completed Phase II trial, patients were treated with AVICINE alone or in combination with Gemzar. The randomized, multi-center trial was designed to evaluate the safety and effectiveness of these treatments. The one-year survival rate for the AVICINE-alone group of approximately 15 percent is similar to that historically reported for Gemzar. Patients in the AVICINE group, however, had no significant vaccine-related side effects, in contrast to the potential for severe side effects associated with Gemzar. The one-year survival rate of approximately 30 percent for the patient group treated with AVICINE plus Gemzar was significantly better than either treatment alone. Patients continue to be monitored for disease progression, with 22 months the longest patient survival to date. It was also found that patients treated with chemotherapy and vaccine together had nearly equivalent antibody responses to vaccine alone, indicating that gemcitabine had little or no impact on pancreatic cancer patients' ability to respond to a new immune challenge.

Principal Investigator John Marshall, M.D. of Lombardi Cancer Center, Georgetown University, Washington, DC, said, "These results compare very favorably to the best published results of chemotherapy alone in this condition. The results in the combination group are the best I've observed with this difficult cancer. The findings provide ample support for AVI's ongoing AVICINE cancer vaccine program."

AVICINE is a therapeutic cancer vaccine that elicits a highly specific immune response to human chorionic gonadoptropin (hCG), a cancer-associated oncofetal protein. The vaccine blocks hCG's function, which is to facilitate tumor growth, angiogenesis, invasion and immunosuppression. The most common side effects of AVICINE are mild reactions at the site of injection. Six completed clinical trials have shown that it is considerably less toxic than traditional chemotherapy. A complete review of the recent data will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting later this month.

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, 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 Phase I/II trials for cancer and polycystic kidney disease. 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 Companies' Securities and Exchange Commission filings.