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

p> interferon potentiates the activity of combination therapy with

nitazoxanide plus peginterferon. The STEALTH C-1(2) trial used 12

weeks of lead-in therapy with nitazoxanide alone. This clinical study

was designed to evaluate the effect of reducing the lead-in phase from

12 weeks to 4 weeks.

In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV

genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide

500 mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and

nitazoxanide for 36 weeks. Romark's STEALTH C-1 trial (see description

above) was used as an historical control, where randomized patients

were treated for 12 weeks with nitazoxanide before adding SOC treatment.

Analysis of data was by intention to treat.

Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of

nitazoxanide followed by the addition of peginterferon for 36 weeks

experienced a SVR 12 weeks after the end of treatment (SVR12) compared

to 50% in the SOC historical control group (P = 0.004), 61% in patients

receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of

nitazoxanide plus peginterferon, and 79% in patients receiving a 12-

week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide

plus SOC.

Of the 44 patients in the study, 78% (n=40) of patients with HCV

genotype 4, 100% (n=3) of patients with HCV genotype 1, and 100% (n=1)

of HCV genotype 2, had undetectable virus at 12 weeks following end of

treatment.

Adverse events reported for these 44 patients were similar to those

reported in the STEALTH C-1 trial. Patients treated with nitazoxanide

experienced no more side effects than patients who received the SOC

therapy. Only one of the 44 patients discontinued therapy
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SOURCE Romark Laboratories
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