Healthcare Industry News: Papillomavirus
News Release - May 2, 2007
Amarillo Biosciences Issues Corporate Update on Influenza and Hepatitis C Research and Behcet's Disease and Oral Warts Phase 2 TrialsAMARILLO, TX--(Healthcare Sales & Marketing Network)--May 2, 2007 -- Amarillo Biosciences, Inc. (ABI) (OTC BB:AMAR.OB ) today issued the following progress report on its influenza research, on plans for a study in 150 patients with hepatitis C, and on its Phase 2 clinical trials in Behcet's disease and oral warts in HIV positive patients. The Company also provided information on its forthcoming Annual Meeting.
Working in collaboration with ABI, Australian and United States researchers conducted a number of studies over the past 15 months exploring the efficacy of low-dose oral interferon against mouse-adapted influenza virus. A leading German research institute has continued this research the past six weeks, challenging laboratory mice with varying doses of an avian influenza strain known as fowl plague virus. Preliminary findings have shown that low-dose oral interferon provides a significant survival benefit against a fatal challenge of this virus. Moreover, when a less-than-fatal dose of the virus was introduced in mice, treatment with oral interferon (compared to placebo) resulted in less weight loss and fewer signs of disease. More work to confirm these findings will be carried out in Germany and Australia in coming weeks. ABI plans to present results of these studies -- along with data from other animal research in Australia, Europe and the U.S. -- as part of its campaign to gain consideration of oral interferon therapy in the debate over how best to cope with a potential flu pandemic.
Hepatitis C Study in Taiwan
In November 2006, CytoPharm, Inc, a Taipei, Taiwan-based biopharmaceutical company, entered into a license and supply agreement with ABI. Under terms of that agreement, CytoPharm has selected hepatitis C as the focus of its first human clinical study. The company earlier had licensed the clinical indications of influenza and hepatitis B. CytoPharm told ABI it hopes to begin enrollment in the 150 patient study of low-dose oral interferon in the fourth quarter of 2007. Current standard therapy for hepatitis C is usually high-dose injectable interferon and ribavirin. Low-dose oral interferon would represent a less toxic and more affordable alternative.
Behcet's Disease Study Adds Two New Sites in Turkey
In an effort to accelerate the completion of its Phase 2 clinical trial on Behcet's disease, an autoimmune disorder, Nobel Ilac Sanayii Ve Ticaret A.S., ABI's Middle Eastern partner, expects to start enrollment this month of Behcet's disease patients at two new clinical sites in Turkey. Nobel has enrolled 62 patients to date, and expects to achieve the full 90-patient enrollment by September. The study is targeted for completion by year-end 2007.
The double-blinded Phase 2 study is testing the efficacy of interferon lozenges versus placebo in the treatment and prevention of mouth ulcers suffered by virtually all Behcet's disease patients. ABI's non-toxic oral interferon represents a significant potential improvement over corticosteroids and other treatment products, which have significant side effects.
Enrollment in Phase 2 Clinical Trial of Oral Warts in HIV+ Patients
Three more clinical sites -- in Philadelphia, Fort Lauderdale and Newark -- have agreed to join the six previously announced sites approved to enroll patients in a study of HIV+ patients suffering from oral warts, a Papillomavirus infection. This placebo-controlled Phase 2 study is a follow-up to two successful studies that have already completed. In the latest study, 57% of HIV+ patients given the optimum dose of oral interferon experienced complete or near complete clearance of their oral warts. As of May 1, 2007, 10 of 80 planned subjects had been enrolled in the new study; complete enrollment is expected by year-end. No products are currently approved by the FDA for this condition, so treatment of oral warts represents a unique market for ABI.
Separately, Amarillo Biosciences announced that its annual shareholders' meeting will be held at 7 p.m. CDT on Friday, June 1, 2007, at the Ambassador Hotel, 3100 I-40 West, in Amarillo, Texas.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 13% of Amarillo Biosciences shares and has provided over $17.8 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, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 22-year history, ABI has invested nearly $38 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 oral interferon therapies. Additional information is available on the ABI 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" of the Company's Form 10-KSB for the year ended December 31, 2006.
Source: Amarillo Biosciences
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