AVI BioPharma Begins Clinical Trial of West Nile Virus Patients
PORTLAND, Ore. - Sept. 10, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII), today announced that it has begun dosing patients in a Phase Ib clinical trial evaluating its West Nile virus NeuGene® antisense drug, AVI-4020. AVI is the first company to begin human testing of a potential antisense treatment for West Nile virus, a seasonal infection transmitted by mosquitoes that last year resulted in 4,156 reported cases, including 284 deaths, in the United States.
The clinical study is being conducted in several medical centers around the country, including those in areas that have been hard-hit by the West Nile virus this year. The trial is designed to evaluate the safety of the drug for patients with severe West Nile infection, and gather the data necessary to potentially design and conduct a pivotal trial in the 2004 West Nile virus season. Dr. Richard Whitley, project director of the National Institute of Allergy and Infectious Diseases' Collaborative Antiviral Study Group, will serve as the principal investigator for the clinical trial.
"Bringing this experimental drug into human patients in just nine months is a tremendous success for our rapid response antisense development platform," said Denis R. Burger, Ph.D., chief executive officer at AVI. "The preclinical results we have seen with this compound, combined with strong safety data from human studies of our NeuGene compounds targeting other indications, form a solid foundation for this clinical program."
The antisense approach to drug discovery can serve as a model for rapid development of drugs to combat emerging infectious diseases. In the case of the West Nile virus, AVI identified a drug candidate, synthesized and manufactured the compound, completed preclinical testing, and submitted an investigational new drug application (IND) in only nine months.
In 2002, according to the Centers for Disease Control and Prevention, 4,156 cases of West Nile virus infection were diagnosed, resulting in 284 deaths. Already in 2003 there have been 2,324 cases of confirmed West Nile infection and 44 deaths. Most people who become infected with West Nile virus have no symptoms, though about 20 percent develop mild, flulike symptoms, including fever, headache, body aches and, occasionally, a rash and swollen lymph glands.
In its most serious manifestations, West Nile virus infection may cause life-threatening inflammation of the brain (encephalitis) or inflammation of the membrane surrounding the brain and spinal cord (meningitis), as well as a number of other significant neurological symptoms, including muscle paralysis similar to that seen with poliovirus infections and others that mimic the symptoms of Parkinson's disease.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene antisense drugs and cancer immunotherapy. AVI's lead NeuGene antisense compound is designed to target cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus, and hepatitis C. AVI's second technology, Avicine®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic and colorectal cancer. 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.