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Romark Announces Data from Clinical Trial of Nitazoxanide in Treatment-naïve Patients with Genotype 1 Chronic Hepatitis C

Romark Laboratories announced results from its STEALTH C-3 clinical trial, a phase 2 clinical study of nitazoxanide in treatment-naïve patients with genotype 1 chronic hepatitis C. Study results were presented as a late breaking communication at the International Liver CongressTM 2010, the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.

The study was a randomized, double-blind, placebo controlled trial conducted at thirteen centers in the United States in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis. A sustained virologic response (undetectable HCV RNA) twelve weeks after the end of treatment (SVR12) occurred in 44% of patients treated with nitazoxanide (500 mg twice daily) plus standard therapy (Pegasys® and Copegus®, F. Hoffman LaRoche) for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR12 rates were consistently higher in subsets of patients with high baseline viral load (41% vs. 29%) and in African Americans (38% vs. 20%). Safety analyses showed that the only adverse events attributable to nitazoxanide, were mild to moderate intermittent diarrhea and discolored urine. Final results of this study will be presented at a late breaking forum of the American Gastroenterological Association Institute during Digestive Disease Week in May of this year.

Results of the STEALTH C-3 study are consistent with previously reported data from studies of nitazoxanide plus Pegasys® and Copegus® in treatment-naïve patients with genotype 4 chronic hepatitis C.1,2 The STEALTH C-3 study is the first trial of nitazoxanide in treatment-naïve 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-François 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. Because of its novel mechanism and safety profile, 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 treating chronic hepatitis C. It is a potent inhibitor of hepatitis C virus in replicon studies,4 and laboratory studies have shown that it does not induce viral mutations that confer drug resistance.5 Nitazoxanide is synergistic with interferon and direct acting antivirals.4,6 In clinical trials in patients with chronic hepatitis C, the addition of nitazoxanide has not resulted in an increase in the toxicity associated with peginterferon and ribavirin. Studies in patients with genotype 4 chronic hepatitis C suggest that nitazoxanide may be used to replace ribavirin.1,2 The AIDS Clinical Trials Group (ACTG) in the United States is studying nitazoxanide plus peginterferon and ribavirin for treating chronic hepatitis C in patients coinfected with HIV.

"Patients with chronic hepatitis C are diverse in many respects with patient and virus characteristics that affect treatment outcomes (HCV genotype, viral load, stage of liver disease, IL28B genotype, race, body weight, coinfection with HIV or hepatitis B virus, and ability to tolerate treatment)," said Emmet B. Keeffe, Chief Medical Officer of Romark Laboratories. "The trend in therapy of chronic hepatitis C has been toward individualized therapy with combinations of antiviral drugs. There is a need for a new class of safe drugs with novel mechanism that can be used in combination with current standard therapy or with other new classes of drugs to improve treatment outcomes. We believe nitazoxanide can play an important role in these combinations."

Another communication of late-breaking data related to use of nitazoxanide plus standard therapy in patients with genotype 1 chronic hepatitis C who previously failed to respond to peginterferon plus ribavirin is scheduled for Saturday, April 17. In keeping with the embargo policy of the conference, the title and authors of the abstract on the nonresponder study are as follows:

Title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide with Peginterferon Alfa-2a and Ribavirin in Nonresponders with Chronic HCV Genotype 1: Final Report Authors: M.L. Shiffman,1 A. Ahmed,2 I.M. Jacobson,3 R.E. Pruitt,4 E.B. Keeffe,2,5 and STEALTH C-2 Investigators. 1Liver Institute of Virginia, Bon Secours Health System, Newport News, VA, USA 2Stanford University Medical Center, Stanford, CA, USA 3Weill Cornell Medical College, New York, NY, USA, 4Nashville GI Specialists, Nashville, TN, USA and 5Romark Institute for Medical Research, Tampa, FL, USA

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 pain and nausea can be common. The current standard treatment of care, peginterferon and ribavirin, is effective in about half of all patients treated. Treatment outcomes vary based on a number of factors including genotype, viral load, genetic factors, stage of liver disease, co-infections and ability to adhere to treatment. According to the Centers for Disease Control, HCV affects an estimated 3.2 million Americans.