Study Concludes AVI BioPharma Antisense Compound Significantly Decreases Cell Proliferation.

Health/Medical Writers

PORTLAND, Ore.--(BW HealthWire)--July 17, 2000

AVI Plans to Initiate Phase I/II Clinical Trials

of Their Antisense Compound in Cancer, Later This Quarter

In a study published in the scientific journal, Antisense & Nucleic Acid Drug Development, scientists at AVI BioPharma, Inc. (Nasdaq:AVIIJ)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) reported that its NEUGENE(R) antisense compound decreased cell proliferation.

The study was designed to evaluate the effectiveness of several morpholine oligomers, a type of antisense agent, against a variety of growth and cell cycle-related genes. The scientists found that oligomers directed against c-myc -- a gene involved in cell proliferation disorders such as cancer and cardiovascular disease -- were the most effective in halting cell growth.

The scientists involved in the study, led by AVI's Senior Vice President of Research and Development Patrick L. Iversen, Ph.D., found that these oligomers compared favorably with the anticancer drug Taxol(R). Based on these results AVI's anti-cancer drug, Oncomyc-NG(TM), will enter Phase I/II clinical trials later this quarter. AVI scientists Robert Hudziak and Dwight Weller and company founder James Summerton were also involved in the study.

The scientists further studied the most effective oligomer to document the mechanism of action of the observed antiproliferative effects. Study data also demonstrate that the observed effects were due to an antisense mechanism. This was a critical feature of the study since the action of other types of antisense compounds can often be attributed to spurious effects.

"Data from this study were very important for us," Iversen said. "They provided the impetus to proceed with other preclinical trials and ultimately, successfully led us into Phase I and Phase II human clinical trials."

Results from this study were included in the Investigational New Drug (IND) application submitted to the U.S. Food & Drug Administration in November, 1999, prior to the Phase I human clinical trial of the compound. After successful completion of the Phase I trial in March, a Phase II clinical trial was initiated. This study is designed to evaluate the therapeutic value of AVI's NEUGENE compounds in treating restenosis following balloon angioplasty. The NEUGENE drug, Resten-NG(TM), is administered at the time of balloon angioplasty in the Phase II human clinical trial.

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(TM), 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 begun Phase II clinical trials of Resten-NG in cardiovascular restenosis, the first application of its novel third-generation NEUGENE antisense technology. 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. More information about AVI is available on the Company's website 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.