AVI confirms efficacy of Neugene against multiple flu strains

By Lisa Kerner

Erie, Pa., Jan. 20 - AVI BioPharma, Inc. said it has confirmation from three independent laboratories of Neugene antisense efficacy in preclinical experiments against multiple strains of influenza, including avian influenza strain H5N1.

Based on these recent findings and results from additional studies, AVI plans to file an Investigational New Drug Application with the Food and Drug Administration for the treatment of influenza A virus with Neugene antisense drugs, company officials said. AVI plans to move into the clinical trial process later this year.

Dr. P. Puthavathana at Mahidol University in Bangkok, Thailand, confirmed Neugene antisense efficacy against an H5N1 viral isolate in her assay system.

Dr. Darwyn Kobasa at the Public Health Agency of Canada in Winnipeg, Man., completed an initial dose-response study in cell culture demonstrating Neugene efficacy against both the H1N1 and H3N2 strains.

Dr. Manoj Pastey at Oregon State University in Corvallis, Ore., confirmed efficacy using the same Neugene antisense agents against the H7N7 and H3N8 strains.

These results confirm efficacy observed with the H1N1 strain previously reported and represent positive reports from four laboratories using different endpoints and methodologies, according to a company news release.

"These confirmations validate our approach to blocking replication of influenza viruses," Patrick L. Iversen, AVI senior vice president of research and development, said in the release. "We now believe that a single Neugene drug could be effective against most influenza subtypes, including the H5N1 avian strain.

"By targeting regions of the viral genetic code that are common to all influenza A subtypes, we expect that our Neugene drugs will be effective against avian flu and the far more common influenza A viruses, which kill an average of 35,000 Americans every year."

AVI is also conducting collaborative animal studies evaluating Neugene efficacy against influenza strains at Tulane University and at the U.S. Army Medical Research Institute of Infectious Disease.

AVI said its Neugene antisense drug development program targets genetic regions of the virus that are highly conserved between six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century and three subtypes of avian flu that have been reported to cause disease in humans.

About 300 patients have been dosed with Neugene drug candidates targeting host and viral gene targets in 12 clinical studies under multiple Investigational New Drug Applications. Five routes of administration have been employed in AVI's clinical studies, and doses up to 450 mg have been administered without a single drug-related, serious adverse event, according to the news release.

Sacramento, Calif.-based AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation Neugene antisense drugs.

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