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Romark Announces Data Presented at AASLD Meeting 2010
Date:11/1/2010

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About Nitazoxanide in CHC

Nitazoxanide, the first of a new class of broad-spectrum antiviral drugs called the thiazolides,(1,2,3) is an investigational new drug for CHC. It is a potent inhibitor of HCV in replicon studies,(2) and laboratory studies indicate that it does not induce viral mutations that confer drug resistance.(3,4) Nitazoxanide is synergistic with interferon and direct acting antivirals in replicon studies.(2,5) In a clinical trial of nitazoxanide monotherapy in patients with genotype 4 CHC, 17% (4 of 23) patients achieved sustained virologic response (undetectable serum HCV RNA 24 weeks after end of therapy), with all responders having low baseline serum HCV RNA levels (<400,000 IU/mL).(6) In other clinical trials, the addition of nitazoxanide to peginterferon or peginterferon plus ribavirin was associated with improvement in sustained virologic response rates without increasing the toxicities associated with peginterferon and ribavirin.(7,8) Romark is preparing to initiate phase III clinical trials of nitazoxanide plus peginterferon for treatment of CHC and has recently announced plans to initiate clinical trials of nitazoxanide in combination with IC41, a therapeutic vaccine under development by Intercell AG.

About Romark Laboratories

Romark Laboratories, L.C. (www.romark.com) is a biopharmaceutical company committed to the discovery and development of innovative new small molecules for treating infectious diseases and cancers.  The Company is developing a new class of broad-spectrum antiviral drugs called the thiazolides. The first thiazolide, nitazoxanide, is an investigational new drug in late-stage clinical development for the treatment of chronic hepatitis C and influenza. Other new thiazolides are expected to enter clinical development in 2011.  Romark markets Alinia® (nitazoxanide) tablets, 500 mg and Alinia® (nitazoxanide) for Oral Su
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SOURCE Romark Laboratories, L.C.
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