Amarillo Biosciences, Inc. Friday announced that they have submitted a final report on the recently completed 200 subject low-dose oral interferon (IFN) Phase 2 clinical trial in Perth, Australia and that this report is available for viewing online on the Amarillo website. Dr. Manfred Beilharz, Chair of Microbiology and Immunology, School of Biomedical, Biomolecular and Chemical Sciences, The University of Western Australia, and one of two principal investigators for the study completed the report.
Amarillo, in global partnership with the Hayashibara Group, a 6% holder of Amarillo Biosciences, has been steadily moving forward with their research and trials of the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including, but not limited to, influenza, hepatitis C and chronic cough. In these Phase 2 clinical trials, the drug’s safety and efficacy was evaluated as a treatment for colds and influenza. A total of 200 healthy human volunteers were enrolled in this study to take a once daily dose of oral interferon or placebo for 16 weeks as prevention of influenza-like illness during the 2009 Australian cold and flu season. The report has been submitted to the State Health Research Advisory Council of the Department of Health, Western Australia (DOH WA).
Quoting the report, the press release mentioned Dr. Beilharz as stating: “The results of the study show that IFN lozenges can be used to significantly reduce the incidence and severity of respiratory symptoms reported by people over the age of 50 years. A 48% reduction in these symptoms was demonstrated in this study, with the potential to save the DOH WA $600,000 to $1.77 million dollars annually depending on the level of treatment uptake by the community. IFN prophylaxis was also found to enhance the effect of the 2009 seasonal influenza vaccine, causing a 39% reduction in the number of vaccinated participants reporting influenza-like illnesses. This was despite the fact that seasonal vaccine had previously been shown to be ineffective against the predominant circulating virus (pandemic influenza H1N1 2009).”
During the 3rd World Summit of Antiviral Summit Shelf in Busan, South Korea (July 31 – August 3, 2010), Dr. Beilharz will report the findings in a presentation titled, “Low Dose Oral Type 1 IFN: A New Defense Against Colds and Flu.”
With regards to studies and usage within the United States and filings with the U.S. Food and Drug Administration (FDA), Dr. Joseph Cummins, CEO of Amarillo, was quoted as stating: “If the use of low-dose oral interferon can save DOH WA millions of dollars as they serve a small population, the potential savings in the U.S. population are vastly greater. We are eager to conduct clinical trials in an effort to achieve FDA approval, to help reduce healthcare costs in the US.”
Amarillo Biosciences, a US biotechnology company, was founded in 1984 and is based in Amarillo, TX. AMAR has approximately 52.8 million shares issued and outstanding with 38.1 million shares in the float. Amarillo is unique in the sense that their interferon alpha is produced naturally from human cells, not by recombinant technology and is given orally in low doses, making the formulation safer and less expensive.