Amarillo Biosciences, Inc. announced that enrolment in a phase II clinical trial of 165 patients with chronic hepatitis C virus infection is now complete. The clinical trial is being conducted in Taiwan and funded by ABI’s strategic partner, CytoPharm, Inc. The aim of the study is to reduce the virologic relapse rate for those patients who have successfully completed standard combination therapy for hepatitis C, which consists of injectable interferon alpha and Ribavirin.
Many patients with hepatitis C are found to be virus-free at the end of standard therapy, but up to half of those with certain viral genotypes relapse in the six months following treatment, once again becoming positive for hepatitis C virus. There are currently no FDA-approved medications shown to reduce the relapse rate for hepatitis C patients, so there is a clear medical need for effective new therapies.
All patients enrolled in this trial first completed standard therapy and were found to be negative for hepatitis C virus. The patients were then assigned to one of two different daily doses of ABI’s human interferon alpha lozenges or placebo for 24 weeks, followed by untreated observation for 24 weeks to check for relapse. All patients are scheduled to complete the untreated observation phase by December 2011, and final results from this important study are expected to be available by the end of next year.
Amarillo Biosciences, Inc. is a US biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.4% 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.