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Findings Include 80% SVR Rate with Nitazoxanide-Based Combination Therapy and New Insights into Mechanism of Action of Nitazoxanide
SAN FRANCISCO, Nov. 3 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that data from studies of nitazoxanide in chronic hepatitis C virus (HCV) infection are being communicated in three presentations made at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting(R), and the 50th Anniversary Meeting of the International Association for the Study of the Liver (IASL) in San Francisco, October 31 - November 4, 2008.
"These new studies confirm earlier data suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained virologic response in a limited number of genotype 1 patients," said Jean-Francois Rossignol, M.D., Chief Science Officer of Romark Laboratories and discoverer of nitazoxanide. "These data also provide interesting insights into the mechanism of action of nitazoxanide, including a potential role for its combination with STAT-C drugs, and confirm previous findings related to its safety."
The three presentations include:
-- "Evaluation of a 4 Week Lead-In Phase with Nitazoxanide (NTZ) Prior
to Peginterferon (PEGIFN) Plus NTZ for Treatment of Chronic Hepatitis C:
Final Report," J.F. Rossignol et al., Sunday, November 2, 4:15 PM
PST (Oral Session IASL #87), and Tuesday, November 4, 8:00 AM - 12:30
PM PST (AASLD Presidential Poster #1848)
In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV
genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide 500
mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and
nitazoxanide for 36 weeks. Data from Romark's STEALTH C-1 trial was used as
an historical control. Analysis of da
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