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Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
Date:8/19/2007

of Hepatitis C) development program is being directed in collaboration with the Division of Gastroenterology and Hepatology at Stanford University School of Medicine by Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr. Rossignol who is also a Stanford affiliate.

Nitazoxanide is the first of a new class of small molecule drugs called the thiazolides that target cell signaling pathways used in viral replication. Data related to the in vitro activity of nitazoxanide against virus replication in hepatitis C virus (HCV) replicons was presented earlier this year at the 20th International Conference on Antiviral Research.

Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston, Texas, said, "The potential for use of nitazoxanide in the treatment of chronic hepatitis C is exciting. To better optimize treatment outcomes for patients, we need new antiviral drugs that can be used safely and effectively in combination with existing drugs or with other new drugs in development."

STEALTH C Clinical Development Program

The US and international clinical trials described above comprise part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.

The STEALTH C-1 trial, conducted in Egypt in interferon-experienced and naive patients with chronic hepatitis C genotype 4, is a phase II randomized controlled trial evaluating the effectiveness and safety of three treatment regimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed by Alinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followed by Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys- Copegus combination therapy for 48 weeks (standard of care
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SOURCE Romark Laboratories, L.C.

Copyright©2007 PR Newswire.

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