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Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
Date:4/18/2008

Trial Marks Third Study in Company's STEALTH C Clinical Program to Evaluate

Nitazoxanide in the Treatment of Chronic Hepatitis C

TAMPA, Fla., April 18 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that it has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008.

The study, STEALTH C-3 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is a Phase II randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alpha-2a (Pegasys(R), Roche) and ribavirin (Copegus(R), Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1.

The primary objective of STEALTH C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus 4 weeks of placebo lead-in followed by 48 weeks of standard of care and placebo. The trial will enroll 60 patients at 15 centers in the U.S.

"Earlier clinical studies in patients with chronic hepatitis C infected with genotype 4 have shown that nitazoxanide improves virologic response rates when used in combination with standard of care," said Dr. Emmet B. Keeffe, Chief Medical Officer of Romark. "This study and our ongoing STEALTH C-2 trial, are designed to evaluate the effect of treatment with nitazoxanide plus standard of care in patients with genotype 1. Future clinical trials will explore new combinations and treatment durations, including current and emerging HCV therapies."

STEALTH C Clinical Development Program

STEALTH C-3 is the latest in a series of clinical trials aimed at gaining a broad understanding of how nitazoxanide may benefit patients with chronic
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SOURCE Romark Laboratories
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