AVI BioPharma Announces Preclinical Testing Plan For SARS Antisense Compound
PORTLAND, Ore. - April 28, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), announced today that it will provide an experimental NeuGene® antisense drug, targeted against the human coronavirus implicated in Severe Acute Respiratory Syndrome (SARS), to the National Institute of Allergy and Infectious Disease (NIAID) for laboratory testing. The compound is expected to be transferred to NIAID this week and is based on genetic sequence information obtained by the company about 10 days ago.
NIAID, a division of the National Institutes of Health, will evaluate the NeuGene compound in culture to determine anti-viral activity against the coronavirus implicated in SARS. In addition, AVI is working to initiate similar experiments at several other laboratories affiliated with the World Health Organization (WHO). The drug has been synthesized and purified at AVI's research facilities in Corvallis, Ore., and will be made available to the other laboratories for cell culture and primate testing on a limited basis.
"Given our successful preclinical experience with NeuGene antisense drugs targeting a wide range of other single-stranded RNA viruses, including three different animal models, we are optimistic about the potential of our technology against the coronavirus," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "We have seen a strong safety profile for NeuGene antisense drugs targeted to a range of other clinical indications in more than 250 patients in nine clinical trials."
AVI's antiviral research program has produced antisense drugs active in preclinical testing against West Nile virus, feline calicivirus, hepatitis C virus and murine hepatitis virus, a coronavirus. Due to their simple genetic structure, single-stranded RNA viruses have proven to be attractive targets for NeuGene antisense drugs.
Antisense drugs are snippets of the genetic sequence of a disease-causing organism, which recognize, lock onto and block replication of the organism. AVI's previous experience with similar viruses provides a template for a possible therapeutic approach to SARS. AVI's proprietary NeuGene antisense chemistry allows the company to rapidly respond to emerging infectious diseases, like SARS. Using its NeuGene antisense drugs, AVI can move from initial target identification to clinical programs quickly, particularly in response to single-stranded RNA viruses.
"While we can't speculate about where this coronavirus testing will take us until we have results from NIAID and others, we believe the antisense approach for rapid responses to emerging infectious agents is sound based on recent preclinical results we have achieved against similar viruses," said Denis R. Burger, Ph.D., CEO of AVI. "I don't know of any other technologies that can produce a potential drug against a new infectious agent in this kind of timeframe. We will work with the NIAID to support the testing process in any way possible and will pursue a range of other preclinical activities to ensure full understanding of the compound."
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 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™, 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 a Phase Ib trial for cancer. AVI has completed three Phase I NeuGene antisense studies that successfully down-regulated the liver enzyme cytochrome P-450 and modified drug metabolism, and a Phase Ib trial in polycystic kidney disease. 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 Company's Securities and Exchange Commission filings.