Amarillo Bioscience Partner, CytoPharm, to Conduct 144 Patient Phase 2 Hepatitis C Trial in Taiwan
Posted on: Tuesday, 19 February 2008, 06:00 CST
Amarillo Biosciences, Inc.(OTCBB: AMAR) today announced that the U.S. Food and Drug Administration has allowed the Investigational New Drug (IND) application submitted by the Company to test its low dose oral interferon in a Phase 2 hepatitis C clinical trial to go into effect. Accordingly, CytoPharm Inc., the Company's partner in Taiwan, will fund and conduct a clinical trial of 144 chronic hepatitis C patients in Taiwan. The patients will receive one of two different dosages of oral human interferon alpha or placebo.
The aim of the trial is to reduce relapse rate for those patients who have completed the standard combination therapy, consisting of high dose injectable interferon alpha and Ribavirin given orally. Although most patients respond to the standard therapy, up to 40% of those with certain viral genotypes relapse after treatment. The trial is expected to start in the 2nd quarter of 2008.
Approximately 170 million people are chronically infected with hepatitis C virus worldwide. The incidence of cirrhosis in chronic hepatitis C patients is 10% to 20% and 1% to 5% develop liver cancer. Infections are transmitted primarily by direct contact with blood through transfusions not screened for hepatitis C virus, inadequately sterilized needles and syringes, sexual and perinatal transmission. There is no effective vaccine against hepatitis C virus.
In addition to studies on hepatitis C, under the terms of the License and Supply Agreement, CytoPharm will be testing oral interferon in human studies of chronic active hepatitis B and influenza.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 11% 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 Sjogren's syndrome, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 23-year history, the Company has invested nearly $39 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/.
About CytoPharm
CytoPharm is a closely held company focusing on the development of biopharmaceuticals for virus-infected diseases and cancers. It was founded in 2002 by Ho Tung Chemical, Vita Genomics, and banks and venture capital firms. It acquired core technologies from Gene Trol Therapeutics, Inc., a California based company through M&A. Its product pipelines contain a series of cytokines induced by its proprietary technologies, used for hepatitis, and cancers. Currently, its product is under clinical trials in China. Both CytoPharm and Vita Genomics are affiliates of Ho Tung Chemical Inc., one of the largest petrochemical companies in Taiwan, and a publicly traded company whose 2006 revenues were approximately NTD 39 billion.
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.
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
SOURCE: Amarillo Biosciences, Inc.
Source: MARKET WIRE
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