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

xanide in combination with Intercell's therapeutic vaccine further underscores our commitment to being a leader in the development of next-generation therapies."

"We are very pleased about this important next step in the development of our vaccine candidate against hepatitis C. The distinctly different mode-of-action and the outstanding tolerability of both treatments creates a joint approach in a field that will continue to have high unmet medical need over the next decades," stated Gerd Zettlmeissl, CEO of Intercell.

Intercell's investigational therapeutic vaccine has been designed to restore an effective immune response against HCV, which ultimately is deemed necessary for sustained clearance of the virus. In a successful proof-of-concept trial involving around 50 treatment-naive genotype-1 CHC patients, an optimized schedule of therapeutic vaccination achieved viral load reductions of more than 75% (0.6 log) in patients with high baseline RNA levels. Importantly, this reduction was sustained for at least six months following the end of treatment. As in previous trials with the vaccine from Intercell, vaccination was safe and well tolerated with minimal side effects.

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
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SOURCE Romark Laboratories, L.C.
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1. Intercell and Romark Join Forces in Combining Therapies Against Hepatitis C
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3. Romark Initiates Clinical Trial of Alinia for Treatment of Influenza
4. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
5. Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008
6. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
7. Romark Laboratories Raises $18 Million in Institutional Financing
8. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
9. Intercell AG Appoints Staph Leavenworth Bakali as Chief Business Officer
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