AVI BioPharma Announces Efficacy of Oral Administration Of Its Proprietary NeuGene Antisense Agents in Rats
PORTLAND, Ore. - March 21, 2002 - AVI BioPharma Inc. (Nasdaq: AVII, AVIIW, AVIIZ) today announced the publication of a peer reviewed study in the Journal of Pharmaceutical Sciences demonstrating effectiveness of its third-generation NeuGene® antisense drugs when administered orally in rats. The results are an important step toward the development of NeuGene compounds as orally administered therapeutic agents.
Study investigators evaluated the effects of oral versus intravenous administration of two separate NeuGene compounds. Bioavailability data was then integrated with in-vivo efficacy of the compounds in two models using distinct gene targets. Results showed that each compound blocked its target gene.
"The results of this study have powerful human implications," said Patrick L. Iversen, Ph.D., senior vice president of research and development for AVI. "With this information, we are much closer to developing oral antisense therapies that will provide patients around the world with more efficacious and cost-effective drugs to treat a broad range of diseases."
The most common challenge of orally administered agents is assuring their integrity and availability to the site of action once the agents are exposed to the gastrointestinal tract. The studies demonstrate AVI's NeuGeneS can pass through the intestinal lining, enter the bloodstream, and be carried to the liver's site of action. Results from the study showed that with oral administration, the availability of study compounds was nearly 80 percent of the availability observed from intravenous injection. In fact, the orally administered NeuGeneS proved more effective than intravenous administration in blocking certain genetic targets.
AVI's NeuGene antisense compounds have been tested in more than 200 human subjects and have been shown to be safe. NeuGene administration in these tests has included intravenous, subcutaneous and oral routes.
AVI has developed third-generation antisense compounds that are more stable, specific, efficacious and safe than other antisense or gene-targeting agents. The company's NeuGene compounds are distinguished by a morpholino-type backbone, which replaces the natural or modified backbones of competing antisense or gene-targeting technologies.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NeuGene 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 in a Phase III pivotal trial in colorectal 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 restenosis and in Phase I/II trials for cancer and polycystic kidney disease. More information about AVI is available on the Company's Web site at 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 Security and Exchange Commission filings.