SOURCE: Amarillo Biosciences, Inc.

February 03, 2010 11:37 ET

Amarillo Biosciences Announces Preliminary Results That Indicate Influenza-Like Illness Incidence Reduced From 71% to 43% in Vaccinated Patients Treated With Oral Interferon, Symptoms Also Lessened

Analysis of Australian Phase 2 Oral Interferon Clinical Trial Continuing

AMARILLO, TX--(Marketwire - February 3, 2010) - Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced preliminary results indicating that, in a recently completed Phase 2 clinical trial conducted in Perth, Australia at the University of Western Australia with Professors David Smith and Manfred Beilharz as principal investigators, the rate of influenza-like illness was significantly (p=0.01) reduced from 71% to 43% in interferon-treated subjects who received Fluvax (an influenza vaccine) prior to the study, compared to subjects in the placebo group who were vaccinated.

While the overall incidence of cold and flu symptoms was similar between the groups, significantly fewer (p < 0.05) subjects in the interferon group experienced moderate to severe feverishness and head congestion, compared to the placebo group. The rate of other moderate to severe cold and flu symptoms was also reduced in the interferon-treated group, but to a lesser degree. The initial analysis shows an overall shift in the interferon group toward milder symptoms, compared to moderate or severe symptoms in the placebo group, regardless of vaccination status.

In this 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.

Blood samples were collected at the beginning and the end of the study, but serology to determine which viruses infected the subjects has not yet been undertaken. The serology will help identify those subjects who had an increase in antibodies to particular cold and flu viruses, including the H1N1 influenza virus which circulated in Perth during the trial period.

These preliminary results from Perth mimic the recent (2007-2009) published reports that mice, guinea pigs and ferrets given interferon orally or intranasally experienced less severe influenza than placebo-treated controls. Moreover, the current results agree with reports published decades ago in the former Soviet Union and Bulgaria that thousands of people had less severe influenza when interferon was given in nose drops.

Assoc. Prof. Manfred Beilharz 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."

Dr. Joseph Cummins, President of Amarillo Biosciences, Inc., remarked, "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." 

About Amarillo Biosciences

Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.9% 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 fiscal year ended December 31, 2008. 

Contact Information

  • Investor Relations:
    Philippe Niemetz
    PAN Consultants, Ltd.
    e-mail:p.niemetz@panconsultants.com
    Tel: 800-477-7570; 212-344-6464
    Fax: 212-618-1276

    Joseph M. Cummins, DVM, PhD
    Amarillo Biosciences, Inc.
    e-mail:jcummins@amarbio.com
    Tel: 806-376-1741 x 13
    Fax: 806-376-9301