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Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008
Date:4/22/2008

Findings Include 80% SVR12 Rate with Nitazoxanide-Based Combination Therapy

and New Insights into Mechanism of Action of Nitazoxanide

MILAN, Italy, April 23 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that data from studies of nitazoxanide in chronic hepatitis C virus (HCV) infection are being communicated in four presentations made at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), held in Milan, Italy this week.

"These new studies confirm earlier data suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained virologic response in a limited number of genotype 1 patients," said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and discoverer of nitazoxanide. "These data also provide interesting insights into the mechanism of action of nitazoxanide and confirm previous findings related to its safety."

The four presentations include:

-- An oral presentation, titled, "Randomized Controlled Trial of

Nitazoxanide-Peginterferon-Ribavirin, Nitazoxanide-Peginterferon and

Peginterferon-Ribavirin in the Treatment of Patients with Chronic

Hepatitis C Genotype 4," reported final 24-week post-treatment

sustained virologic response (SVR) rates for the company's STEALTH C-1

trial.

In the trial, 96 treatment-naive patients with chronic hepatitis C

genotype 4 were randomized into three groups to receive either 48 weeks

of standard of care (SOC) treatment (n=40), 12 weeks of nitazoxanide

followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen,

n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide

plus SOC with peginterferon plus ribavirin (a triple regimen, n=28). An

additional 24 interferon-experi
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SOURCE Romark Laboratories
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