Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that it has agreed to a strategic partnership with Intas Pharmaceuticals Limited (Intas), one of the top 20 pharmaceutical companies in India, whereby Intas will sponsor clinical trials of ABI's orally administered interferon-alpha lozenges in order to combat influenza. Intas will pay ABI a royalty on net sales after marketing approval is obtained in India.
The H1N1 virus continues to circulate in India. Recent reports place the death rate in India from H1N1 infection at 3.1%. The objective of the clinical trials in India is to determine the efficacy of low dose oral interferon in reducing the severity of infection with influenza viruses such as H1N1.
ABI has been conducting studies on the use of low-dose interferon to treat and prevent respiratory tract disease in animals and has found it to be a safe, effective oral therapy for cats, cattle, and horses. Others have published that oral interferon is an effective treatment of human influenza.
In a Phase 2 clinical trial being conducted in Perth, Western Australia, volunteers are being given ABI's low-dose oral interferon for prevention and treatment of influenza. The study, which is being conducted by researchers at the University of Western Australia and funded by the Health Department of Western Australia, is nearing completion. This double-blind, placebo-controlled trial is expected to show that ABI's orally administered interferon lozenges can safely reduce both the infection rate and the severity of symptoms in subjects who are exposed to influenza and other respiratory viruses during a typical flu season. The company plans to release the results of this important study before the end of the year.
A month ago, the President's Council of Advisors on Science and Technology suggested a "plausible scenario" that 40% of the US population could be infected by the H1N1 virus, which, according to the US Centers for Disease Control and Prevention, is widespread in 27 states and regional in 18 other states. Even though the "2009-2010 influenza season" didn't officially begin until October 4, there have already been 60 pediatric deaths attributed to the H1N1 virus in the US.
"Influenza viruses mutate to evade the effects of anti-viral drugs. Influenza viruses do not mutate to evade interferon, but instead they have a strategy to sabotage the host interferon system. By giving people interferon orally, we believe we can overcome this viral strategy. It is my belief that low-dose oral interferon will be a beneficial therapy of all influenza viruses, not just the H1N1 strain," said Dr. Joseph M. Cummins, President and CEO of ABI.
A call for robust H5N1 influenza preparedness and response