Amarillo, Texas, May 20, 2009 — Amarillo Biosciences, Inc. (AMAR) (OTCBB: AMAR) today announced that it has selected Accelovance, Inc., a clinical research organization (CRO) based in Rockville, MD, to conduct a human clinical study of the company’s oral interferon product during the upcoming 2009/2010 influenza season in the US. This new Phase 2 clinical trial will be a follow-up to the ongoing study at the University of Western Australia being conducted by Dr. Manfred Beilharz and colleagues, which is expected to show that lozenges containing a low dose of interferon-alpha can prevent infection or reduce the severity of infection with influenza and other common respiratory viruses when taken once a day during a typical winter cold/flu season. The study in Australia is well under way, with over 100 healthy adult volunteers screened to date for inclusion in the trial.
For the new study, Accelovance will enroll 400+ healthy volunteers at six wholly-owned research dedicated clinical centers spread across the United States. Beginning in December 2009, volunteers will take one of three doses of oral interferon lozenges or placebo once a day for the next 16 weeks, to coincide with the December-March flu season in the US. The aim of the study is to identify the dose of oral interferon with the best profile of safety and efficacy at preventing influenza and winter colds. This best dose of oral interferon will be used in a Phase 3 study to be conducted during the May-August 2010 influenza season in Australia.
“Accelovance is excited about the opportunity to partner with Amarillo Biosciences in carrying out this important study of interferon lozenges for the prevention of winter colds and flu during the upcoming US influenza season,” said Steven J. Trevisan, President and CEO of Accelovance. “Accelovance has demonstrated performance with healthy volunteer clinical studies and has experience with seasonal cold/flu, pandemic flu and rhinovirus research,” Mr. Trevisan added. “This study will benefit from our integrated service offering of flexible CRO services, clinical research sites, and patient management solutions; operational efficiencies that allow us to achieve rapid patient enrollment, excellent patient retention, and timely delivery of high quality study data.”
Dr. Joseph Cummins, President, CEO of AMAR said, “Some strains of influenza virus have already developed resistance to currently available antiviral drugs, and more strains are likely to become resistant over time. Therefore, it is critical to identify alternative therapies. Unlike antiviral drugs that act directly against influenza, which can lead to viral resistance, AMAR’s oral interferon product works indirectly by boosting the immune system, making the development of viral resistance highly unlikely. This new study is the next step in proving that our low-dose interferon lozenges can be a safe and effective alternative to antiviral drugs for influenza.” Dr. Cummins added, “Our human studies continue to build on the published work by Dr. Beilharz (Biochemical and Biophysical Research Communications 355:740-744, 2007), which shows that low dose oral interferon can prevent death in mice infected with mouse-adapted H1N1 influenza virus.”
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 7% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. In its 25-year history, the Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web site at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company’s other product candidates and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. In particular, see “Item 1. Description of Business” and “Item 7A. Qualitative and Quantitative Disclosures About Market Risk” of the Company’s Form 10-K for the year ended December 31, 2008. --END--