Amarillo Bio Enters Into License, Supply Agreement With Intas Pharma

Intas intends to launch a double-blind, placebo-controlled Phase 3 clinical trial of ABI’s orally administered interferon-alpha lozenges in India before the end of March. The study will involve up to 520 patients with clinical symptoms and signs of influenza. Intas will pay ABI a royalty on net sales in India and Nepal after marketing approval is obtained.

The goal of the clinical trial planned in India is to ascertain the efficacy and safety of low dose oral interferon in mitigating the severity of infection with influenza viruses such as H1N1. A Phase 2 clinical trial recently completed in Perth, Australia showed that ABI’s interferon-alpha lozenges were beneficial and safe when given as prevention against respiratory viruses, including influenza.

In the double-blind study that was conducted in Perth, 200 healthy volunteers were given ABI’s low-dose interferon-alpha lozenges or placebo once a day for 16 weeks during the winter cold and flu season in Western Australia.

The company claimed that, according to the preliminary analysis, interferon-alpha lozenges were free from adverse effects and caused a shift in symptom severity from moderate to mild. Prophylactic use of low-dose interferon-alpha lozenges considerably reduced the rate of influenza-like illness in study volunteers ages 55 years and older, who are generally considered prone to get affected by influenza. The company intends to release full study results when serology testing is completed.

Dr. Joseph Cummins, president and CEO of ABI, said: “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.”