Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the Uni...( International Clinical Data to be Pr...)

International Clinical Data to be Presented at the 58th Annual Meeting of

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

TAMPA, Fla., Aug. 15 /PRNewswire/ -- Romark Laboratories announced that it has initiated a phase II clinical trial of Alinia(R) (nitazoxanide) for treating chronic hepatitis C in the United States.

The clinical trial is designed to evaluate the effectiveness and safety of Alinia tablets administered in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin). Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.

"We are excited to be participating in this clinical trial," said David Nelson, M.D., Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section at the University of Florida. "There is a critical need for new therapies for patients with hepatitis C, particularly those who have already failed existing therapies."

The company also announced that interim data from an international clinical trial in patients with chronic hepatitis C will be communicated at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.

"Initiation of the US study and communication of our international data represent important milestones for our development program," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark who invented nitazoxanide and is leading its clinical development. "We are enthusiastic about the results to be presented at the upcoming AASLD meeting and the opportunity to develop an important new treatment for patients suffering from chronic hepatitis C."

The company's STEALTH C (Studies to Evaluate Alinia for Treatment
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SOURCE Romark Laboratories, L.C. Copyright©2007 PR Newswire.

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