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Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C
Date:10/21/2010

TAMPA, Fla., Oct. 21 /PRNewswire/ -- Romark Laboratories, L.C. and Intercell AG (VSE; "ICLL") today announced plans to commence clinical trials of Romark's antiviral drug, nitazoxanide, in combination with Intercell's investigational therapeutic hepatitis C virus (HCV) vaccine, IC41, during the first half of 2011.

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Intercell's vaccine candidate has demonstrated a sustained reduction of viral load in chronic hepatitis C (CHC) patients in a phase II proof-of-concept trial. Nitazoxanide is an oral therapy that targets host cell factors involved in HCV replication and is not associated with viral mutations conferring resistance. Nitazoxanide has been shown to induce sustained virologic response as monotherapy in some patients chronically infected with HCV.

The planned European phase II trial will include approximately 60 treatment-naive patients chronically infected with HCV genotype-1 in three treatment arms: (1) IC41 plus nitazoxanide, (2) IC41 plus nitazoxanide and Pegasys® (peginterferon alfa-2a) and (3) Pegasys and Copegus® (ribavirin), the current standard of care, as an active control. The primary endpoint will be sustained virologic response (no detectable HCV RNA 24 weeks after end-of-treatment). The companies involved in the combination study will retain commercial rights for their respective products.

"We are excited about this novel therapeutic approach for chronic hepatitis C," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "There is an important need for novel therapies that offer improvements in safety and efficacy compared to current standard therapy. Our development program for nitazoxanide in combination with peginterferon addresses this need and promises to change paradigms for therapy of chronic hepatitis C. The planned study of nitazo
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SOURCE Romark Laboratories, L.C.
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