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Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
Date:5/21/2008

TAMPA, Fla., May 21 /PRNewswire/ -- Romark Laboratories, L.C., a privately-owned biopharmaceutical company, today announced the completion of enrollment into its Phase II clinical trial to evaluate the safety and efficacy of nitazoxanide in combination with standard of care therapy in U.S. patients with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care therapy (peginterferon and ribavirin). The company expects to announce interim data results at a medical meeting this fall. Romark recently announced the initiation of a Phase II trial of nitazoxanide in treatment-naive patients with chronic hepatitis C infected with genotype 1 (STEALTH C-3).

"Completing enrollment in this Phase II trial is a significant achievement for Romark and an important step in the clinical development of nitazoxanide," stated Marc Ayers, Chief Executive Officer of Romark. "We believe nitazoxanide represents a promising approach to the treatment of hepatitis C for the millions of people who are infected with this serious liver disease."

The study, called STEALTH C-2 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is the second in a series of clinical trials designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with Pegasys(R) (peginterferon alfa-2a) or peginterferon and Copegus(R) (ribavirin) in patients with chronic hepatitis C. STEALTH C-2 is a randomized, double-blind, placebo-controlled trial conducted in the United States in 60 patients with chronic hepatitis C genotype 1, who are non-responders to prior peginterferon and ribavirin therapy. The study is designed to evaluate the effectiveness and safety of nitazoxanide administered 500 mg twice daily for four weeks followed by nitazoxanide plus Pegasys plus Copegus combination therapy for 48 weeks, compared to placebo for four weeks followed by placebo plus Pegasys plus Copegus combination therapy for 48 weeks. Pegasys and Copegus are be
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SOURCE Romark Laboratories, L.C.
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