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Romark Announces Presentation of New Data for Controlled Release Nitazoxanide in Chronic Hepatitis C
Date:2/17/2009

Studies presented at the 19th Conference of the Asian Pacific Association for the Study of the Liver (APASL) Demonstrated Favorable Pharmacokinetics and Significant Reduction in Viral Load

TAMPA, Fla., Feb. 17 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced results from international Phase I and II clinical trials evaluating a controlled release version of nitazoxanide in the treatment of chronic hepatitis C virus (HCV) infection. In the phase II study in treatment-naive patients infected with HCV genotype 4, 82% (n=17) and 100% (n=16) of patients receiving low and high doses of controlled release nitazoxanide, respectively, experienced undetectable serum HCV RNA (<12 IU/mL) after 12 weeks of combination therapy with peginterferon and ribavirin.

The data, part of Romark's OPTIMA HCN (OPTImizing MAnagement of Hepatitis C with Nitazoxanide) development program, were presented this weekend in an oral presentation at the 19th Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Hong Kong. The presentation titled "Controlled Release Tablet Improves Pharmacokinetics, Viral Kinetics and Tolerability of Nitazoxanide for Treatment of Chronic Hepatitis C," abstract FP052, was given by Emmet B. Keeffe, M.D. of the Romark Institute for Medical Research, Tampa, FL.

"We continue to be encouraged by the results of the ongoing nitazoxanide clinical development program," said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and discoverer of nitazoxanide. "These data show that controlled release nitazoxanide exhibits favorable pharmacokinetics and tolerability, and - in combination with the standard of care therapy - robust antiviral activity in a small number of patients with HCV genotype 4. We look forward to reporting interim data from our U.S. studies evalua
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