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news.Romark Laboratories has released results from its Stealth C-3 clinical trial, a Phase 2 clinical study of Nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. Study results were presented at forum of the American Gastroenterological Association Institute (AGA Institute) during Digestive Disease Week 2010 in New Orleans, Louisiana.
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The study was a randomised, double-blind, placebo controlled trial conducted at 13 centers in the US in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis.
In the trial, 112 patients were randomised to receive either Nitazoxanide (500mg twice daily) plus peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) or placebo plus Pegasys and Copegus.
The primary endpoint of the study was sustained virologic response (SVR, undetectable HCV RNA 24 weeks after the end of treatment). SVR occurred in 44% of patients treated with Nitazoxanide plus standard therapy for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR rates were consistently higher in subsets of patients with high baseline viral load (41% vs 29%) and in African Americans (38% vs 20%).
Additionally, 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. The Stealth C-3 study is the first trial of Nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C.
Jean-Francois Rossignol, chairman and chief science officer of Romark and inventor of the drug, said: “We are pleased to achieve these results in a population representative of the broad range of hepatitis C patients in the US, including 35% with advanced fibrosis.
“We plan to initiate phase 3 clinical trials of Nitazoxanide using our 675mg controlled release tablets in combination with peginterferon with or without ribavirin later this year. The 675mg controlled release tablets deliver a higher dose of Nitazoxanide with a better pharmacokinetic profile.
“Additional clinical trials using the 675mg 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.”