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

enced patients were randomized to

receive 12 weeks of nitazoxanide followed by either the dual regimen

(n=12) or the triple regimen (n=12) for 36 weeks. Patients received

peginterferon alfa-2a (Pegasys(R), Hoffman LaRoche) 180 micrograms once

per week; nitazoxanide was administered as one 500 mg tablet twice

daily; and ribavirin (Copegus(R), Hoffman LaRoche) was administered as

1,000 or 1,200 mg daily according to body weight. Analysis of data was

by intention to treat.

In treatment-naive patients, combination therapy with nitazoxanide plus

SOC resulted in a SVR24 rate of 79%, compared with 50% for those

treated with SOC without nitazoxanide (P=0.023). When nitazoxanide was

combined with peginterferon alone, the observed SVR24 rate in this

group was 61%. In 24 treatment-experienced patients, the addition of

nitazoxanide to SOC for 36 weeks resulted in a 25% rate of SVR,

compared with 8% when nitazoxanide was combined with peginterferon

alone. The patients treated with nitazoxanide experienced no more side

effects than patients who received the SOC.

Interim results of this trial were presented at the 58th Annual Meeting

of the American Association for the Study of Liver Diseases (AASLD) in

Boston, MA.(1)

-- A poster presentation, titled "Evaluation of a 4-week Lead-in Phase

With Nitazoxanide Prior to Nitazoxanide+Peginterferon in Treating

Chronic Hepatitis C," demonstrated that reducing a nitazoxanide lead-in

phase from 12 to 4 weeks, followed by the addition of SOC therapy, does

not compromise virologic response rates in a patient population with

different genotypes, predominately genotype 4.

Replicon studies and an early clinical experience (unpublished)

indicated that treatment with nitazoxanide alone prior to adding

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SOURCE Romark Laboratories
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2. Romark Laboratories Raises $18 Million in Institutional Financing
3. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
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