SOURCE: Amarillo Biosciences, Inc.

May 05, 2005 10:34 ET

Amarillo Biosciences, Inc. Receives Another SBIR Grant to Develop Vaccine and Oral Cytokine Therapy for Helicobacter Pylori

Helicobacter Pylori Is a Major Cause of Gastric Cancer

AMARILLO, TX -- (MARKET WIRE) -- May 5, 2005 -- Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR) today announced that the Company has received a Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH). The SBIR grant is for $104,372 and will be used by Amarillo Biosciences to further develop a vaccine to combat Helicobacter pylori (H. pylori), a major cause of gastritis and gastroduodenal ulcer disease in humans. Amarillo Biosciences will collaborate with Steven Krakowka, DVM, PhD of The Ohio State University.

H. pylori is a spiral-shaped bacterium that is found in the stomach of humans in which it causes more than 90% of duodenal ulcers and up to 80% of gastric ulcers. In developing countries, infection is frequently symptomatic and is thought to be responsible for the high incidence of gastric cancer in those areas. The cost and expense of pharmacological intervention is beyond the means of most of the world's population. A safe and effective vaccine, or affordable therapy could provide significant relief to the infected population.

Dr. Joseph M. Cummins, President and CEO of Amarillo Biosciences, Inc., said, "Data generated from our vaccine trials in swine will provide the basis for future studies in humans. We are excited to partner with Dr. Krakowka who has the expertise to make this a successful vaccine for a major disease worldwide."

"Preliminary data in the gnotobiotic piglet model of H. pylori are very encouraging," says Dr. Krakowka. "The piglet model was the first non-primate animal developed for this disease and is widely used in drug screening and efficacy trials. In this regard, the piglet, unlike rodents, is physiologically similar to humans. In a previous SBIR grant, we demonstrated that parenteral vaccinations with a nonliving and nontoxic H. pylori vaccine preparation prevented gastric colonization in 80% of challenged swine. In this application, we will extend these studies to explore the feasibility of using this vaccine for the prevention of recrudescence of the infection in swine treated with antimicrobial agents. In the developed world, medicinal treatment failures and re-appearance of the infection and gastritis after completion of therapeutic regimens are major complications of antimicrobial therapy. We have good preliminary evidence which suggests that orally administered interferons will prevent gastric colonization by this microbe. We are very excited about this opportunity to explore this phenomenon in greater detail," said Krakowka.

Under the terms of the SBIR grant, ABI will fund the research and development of a vaccine and an oral interferon cocktail formulation for use as an adjunct to antimicrobial therapies. If the Phase I work goes as expected, ABI will request a larger Phase II SBIR grant in 2006 to fund human trials.

About Amarillo Biosciences, Inc.

Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 20.6% of Amarillo Biosciences shares and has provided over $16.5 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 Sjogren's syndrome, Behçet's disease, and opportunistic infections in patients who are HIV positive. In its 20-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The overwhelming majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at

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" of the Company's Form 10-KSB for the year ended December 31, 2004.

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