Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the Uni... (). The study randomized 120 patients. Pa...)

Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States

Date:8/19/2007

). The study randomized 120 patients. Patients enrolled in this trial have reached the end of treatment and are undergoing follow-up for sustained virologic response. Data from the STEALTH C-1 clinical trial is expected to provide important efficacy and safety data that will guide the continuing development of nitazoxanide for treating chronic hepatitis C. Interim data from this trial will be presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.

The STEALTH C-2 trial is a randomized double-blind placebo-controlled trial conducted in the United States in 60 patients with chronic hepatitis C genotype 1 who have previously failed to respond to peginterferon and ribavirin combination therapy. This trial is designed to evaluate the effectiveness and safety of Alinia administered 500 mg twice daily for 4 weeks followed by Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for 4 weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks (standard of care).

About Hepatitis C

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a virus spread through direct contact with the blood of infected people. Chronic HCV infection may cause liver cirrhosis or hepatocellular carcinoma. An estimated 3.2 million people in the U.S. are chronically infected by hepatitis C virus. Globally, an estimated 170 million people are chronically infected, with three to four million persons newly infected each year, according to the World Health Organization.

About Romark Laboratories

Romark Laboratories, L.C. (http://www.romark.com) is a biotechnology company committed to the discovery and development of innovative new small molecules for treating infectious diseases, cancers, and autoimmune diseases.

About Alinia

Alinia (nitazoxanide) is indicated in the United States for treat
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SOURCE Romark Laboratories, L.C.

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Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the Uni...(). The study randomized 120 patients. Pa...),Health