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Romark Announces Final Data From Clinical Trial of Nitazoxanide in Treatment-Naive Patients With Genotype 1 Chronic Hepatitis C
Date:5/4/2010

s showed the rate of serious adverse events were similar for the nitazoxanide and placebo treatment groups.  The only adverse events significantly associated with nitazoxanide were mild to moderate intermittent diarrhea and discolored urine.

Results of the STEALTH C-3 study are consistent with previously reported data from studies of nitazoxanide plus Pegasys® and Copegus® in treatment-naive patients with genotype 4 chronic hepatitis C.(1,2)  The STEALTH C-3 study is the first trial of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C.  

"We are pleased to achieve these results in a population representative of the broad range of hepatitis C patients in the United States, including 35% with advanced fibrosis," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark and inventor of the drug.  "We plan to initiate phase 3 clinical trials of nitazoxanide using our 675 mg controlled release tablets in combination with peginterferon with or without ribavirin later this year.  The 675 mg controlled release tablets deliver a higher dose of nitazoxanide with a better pharmacokinetic profile.   Additional clinical trials using the 675 mg controlled release tablets in genotype 1 and 4 patients are underway and include reduction of the duration of peginterferon to 24 weeks with and without ribavirin.  We also plan to investigate combinations with direct acting antiviral drugs.  Ultimately, we expect nitazoxanide to play an important role in a broad range of patients with chronic hepatitis C."

Nitazoxanide, the first of a new class of broad spectrum antiviral drugs called the thiazolides, (3,4,5) is an investigational new drug for chronic hepatitis C.  It is a potent inhibitor of hepatitis C virus (HCV) in r
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SOURCE Romark Laboratories, L.C.
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