Amarillo Biosciences And CytoPharm Announce Start Of Enrollment For Hepatitis C Study In Taiwan

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Jun 2009 - 6:00 PDT

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Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) and CytoPharm, Inc. today jointly announced the start of enrollment for a study of ABI's oral interferon-alpha lozenges for chronic hepatitis C virus infection. The aim of the trial is to reduce the virologic relapse rate for those patients who have completed the standard combination therapy, which consists of high dose injectable interferon-alpha and Ribavirin. Although most patients respond to the standard therapy, up to 50% of those with certain "high-risk" viral genotypes relapse after treatment.

The study will be conducted under the direction of Dr. Chau-Ting Yeh at the Chang Gung Memorial Hospital in Taipei, Taiwan. A total of 165 patients who test positive for a "high-risk" hepatitis C viral genotype will receive one of two different doses of human interferon-alpha or placebo given daily for 24 weeks. Following completion of treatment, patients will be monitored for relapse for an additional 24 weeks. Full study enrollment is expected by the end of the year with study completion targeted for the 4th quarter of 2010.

Approximately 170 million people are chronically infected with hepatitis C virus worldwide, with an additional 3-4 million cases occurring each year. The incidence of cirrhosis in chronic hepatitis C patients is 10 to 20%, and 1 to 5% develop liver cancer. In addition to sexual and perinatal transmission, hepatitis C virus infection is common following direct contact with contaminated blood, typically due to inadequately sterilized needles and syringes. Currently, there is no effective vaccine against hepatitis C virus.

Separately, the companies announced that CytoPharm is planning a study of oral interferon lozenges in the treatment of influenza to be launched during the 2009/2010 flu season in Taiwan.

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/.

Source
CytoPharm