Amarillo Reports Preliminary Results Of Phase 2 Trial

In the study, 200 healthy human volunteers took a once daily dose of oral interferon or placebo for 16 weeks during the Australian cold and flu season. There was a 4-week untreated follow-up period, so each subject’s participation in the study was 20 weeks. The study was funded by the Department of Health Western Australia and ABI, which supplied the low dose interferon alpha and matching placebo used in the trial.

Manfred Beilharz, principal investigator of the study, said: “In my opinion, compared to the toxicity and expense of Tamiflu, prophylactic low dose oral interferon may be superior in managing influenza. Ten doses of Tamiflu over 5 days were compared in 2009 to two doses of intranasal interferon in ferrets.

“Interferon was as good or better in every comparison (less flu virus in nasal washes, reduction in clinical signs and more exercise endurance). The human data from Perth will guide the design of a follow-up clinical trial to start in May 2010 in the same city. Further analysis of the data from the Perth study including the serology and detailed stratification will be announced as it becomes available.”

Joseph Cummins, president of Amarillo, said: “These human results are quite similar to results when oral interferon was given to animals. Oral interferon has been tested extensively in dogs, cats, horses, cattle, hogs and mice. In nearly every animal study, oral interferon did not stop disease, but instead modified the disease so it was less severe than disease in animals given placebo.

“When dosed with oral interferon, dogs with parvovirus, cats with feline leukemia, cattle with respiratory tract disease (‘shipping fever’), horses with inflammatory airway disease, hogs with various viral infections and mice with influenza had less severe disease and a shorter duration of illness.”