Amarillo Biosciences, Inc. (OTCBB: AMAR) today announced that a Phase 2 study of orally administered interferon-alpha for the prevention of influenza and winter colds has reached the midway point. The study in Perth, Australia achieved full target enrollment of 200 subjects and 98% of the subjects remain on study drug. Subjects in the study are receiving a lozenge containing interferon-alpha or a matching placebo once a day for 16 weeks. The average treatment time in the study to date is just over eight weeks. The first subject began treatment in May and the last subject will be completing blinded treatment in November, with final study results expected before the end of the year.
Study medication compliance has been excellent and is averaging 95% per week (i.e. 19 out of every 20 expected doses of study drug is being taken by the subjects). Safety has been excellent with no serious adverse events reported and only 4 drop-outs to date.
The H1N1 virus has been circulating in Perth since the study began. Presumably, some subjects in the study have been exposed to H1N1 virus. This Phase 2 clinical trial's objective is to determine the efficacy of low dose oral interferon in preventing and reducing the severity of infection with influenza viruses such as H1N1, among others.
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