AVI BioPharma Updates Progress in Single Stranded RNA Viruses With NeuGene Antisense Compounds
Third-Generation Antisense Appears Promising in Bioterrorism, SARS settings
PORTLAND, Ore. - March 20, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced further promising preclinical results in its viral program, which currently focuses on single stranded RNA viruses. The program uses the company's proprietary NeuGene® antisense agents to target this family of viruses, which includes many of the viruses on the Domestic Homeland Security list of bioterrorism viruses, as well as hepatitis C virus, West Nile virus, Calicivirus, and may include severe acute respiratory syndrome (SARS).
In Calicivirus, AVI had previously reported a successful study where kittens treated with NeuGene survived a Feline Calicivirus outbreak in Atlanta. The company recently completed a second preclinical trial against Feline Calicivirus in 13 mature cats. In this study, the symptoms of the virus, which include upper respiratory problems, conjunctivitis, peripheral edema and hemorrhages, were observed to be greatly reduced in the treated cats.
"These results continue to demonstrate the safety and efficacy of our third-generation NeuGene antisense," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "Feline Calicivirus is considered to be an appropriate model for the treatment of human Norwalk virus, the virus that plagued the cruise ship industry this summer, and is indicative of the broad utility of our compounds in single stranded RNA viruses."
AVI had previously reported successful preclinical efforts in West Nile virus in a penguin population in Wisconsin. The company is now completing toxicity and pharmacokinetic analyses in preparation for filing an Investigational New Drug (IND) application for a clinical trial this summer.
"The preclinical results obtained with NeuGene antisense in the family of single stranded RNA viruses in multiple settings may demonstrate even broader promise for combating other single stranded RNA viruses, like those feared in bioterrorism, and for SARS," said David O. Matson, M.D., Ph.D., head of Infectious Disease Section and associate director of the Center for Pediatric Research, Eastern Virginia Medical School, in Norfolk, Va.
AVI believes that its proprietary NeuGene antisense technology could be targeted against most of the Domestic Homeland Security list of viruses for bioterrorism. Critical to this effort, as it has been in the outbreaks of both Calicivirus and West Nile virus, is the company's ability to respond rapidly and create efficacious drugs. In the case of these outbreaks in animals, AVI manufactured its antisense drugs within a seven- to 10-day period from the identification of the genetic code in the viral outbreaks.
"No other drug development technology, or other antisense technology, could respond this quickly to a viral outbreak scenario," said Denis R. Burger, Ph.D., chief executive officer at AVI. "The unique targeting characteristics of our compounds made these response times a reality."
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.