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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

ing provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.

Romark recently announced enrollment for its STEALTH C-3 clinical trial, a Phase II randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alfa-2a and ribavirin in treatment nave patients with chronic hepatitis C infected with genotype 1. Enrollment for the STEALTH C-3 study began in April 2008 and the trial will enroll 60 patients at 15 centers in the U.S.

The primary objective of STEALTH C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus 4 weeks of placebo lead-in followed by 48 weeks of standard of care and placebo.

About Nitazoxanide

Nitazoxanide belongs to a new class of small molecule kinase activators called the thiazolides. Like interferons, thiazolides modulate cell signaling pathways involved in the host cell's innate defense against viruses. Thiazolides can be administered orally and are not associated with side effects commonly associated with use of interferon. Nitazoxanide was discovered by Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark, and was initially developed by Romark and approved for marketing in the United States as a treatment for cryptosporidiosis. Recent laboratory studies have shown that nitazoxanide does not induce resistance mediated by mutations in the viral genome.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease that is caused by the hepatitis C virus (HCV). It is the most common cause of chronic hepatitis in the U.S. and may eventually lead to cirrhosis, liver cancer and liver failure. The disease is transmitted by contact with HCV-infected blood. A large majority of those infected do not show symptoms, but fatigue, abdominal pa
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SOURCE Romark Laboratories, L.C.
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