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news.Romark Laboratories has initiated a Phase II clinical trial of Alinia treating chronic hepatitis C in the US.
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The clinical trial is designed to evaluate the effectiveness and safety of Alinia tablets administered in combination with Pegasys and Copegus in 60 patients with chronic hepatitis C genotype I who have failed to respond to standard therapy (peginterferon and ribavirin). Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche.
“Initiation of the US study and communication of our international data represent important milestones for our development program,” said Jean-Francois Rossignol, chairman and chief science officer of Romark who invented Alinia (nitazoxanide) and is leading its clinical development.
Nitazoxanide is the first of a new class of small molecule drugs called the thiazolides that target cell signaling pathways used in viral replication.
Stephen A. Harrison, chief of hepatology at Brooke Army Medical Center in Fort Sam Houston, Texas, said: “To better optimize treatment outcomes for patients, we need new antiviral drugs that can be used safely and effectively in combination with existing drugs or with other new drugs in development.”
The company has carried out a Stealth C-1 (studies to evaluate Alinia for treatment of hepatitis C) clinical development program in Egypt, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.
The Stealth C-1 trial is a Phase II randomized controlled trial evaluating the effectiveness and safety of three treatment regimens: Alinia administered 500mg twice daily for 12 weeks followed by Alinia-Pegasys combination therapy for 36 weeks; Alinia 12 weeks followed by Alinia-Pegasys-Copegus combination therapy for 36 weeks and Pegasys- Copegus combination therapy for 48 weeks (standard of care). The study randomized 120 patients. Patients enrolled in this trial have reached the end of treatment and are undergoing follow-up for sustained virologic response.
Data from the Stealth C-1 clinical trial is expected to provide important efficacy and safety data that will guide the continuing development of nitazoxanide for treating chronic hepatitis C. Interim data from this trial will be presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.