AVI BioPharma, Inc. released data compiled from its Phase I/II West Nile virus (WNV) clinical trial with its proprietary NeuGene antisense drug, AVI-4020. The primary objective of the trial was to assess safety, and AVI-4020 demonstrated a safety profile consistent with the other NeuGene antisense drugs. No safety concerns pertaining to the drug were identified during the study.
The trial enrolled 10 patients, nine of whom received AVI-4020 and one of whom received a placebo. The trial was conducted in Colorado at the Boulder Community Medical Center. The state of Colorado had the highest rate of West Nile virus reported in 2003.
"This study provides additional evidence demonstrating the viability of our infectious disease programs," said Denis R Burger, PhD, chairman and CEO of AVI BioPharma. "These data, combined with the results of our other extensive efforts in viruses, lay the groundwork for advancing in 2004 into viruses that are major worldwide unmet medical needs, like hepatitis C and dengue virus."
As of Dec. 17, 2003, according to the Centers for Disease Control and Prevention, 8,912 cases of West Nile virus were reported, which included 211 deaths. Although the majority (6,066 or 68 per cent) of those were reported with the milder form of the disease, 30 per cent or 2,641 patients contracted the serious form of WNV disease (meningitis or encephalitis).
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene antisense drugs and cancer immunotherapy.