TAMPA, Fla., May 21 Romark Laboratories, L.C., aprivately-owned biopharmaceutical company, today announced the completion ofenrollment into its Phase II clinical trial to evaluate the safety andefficacy of nitazoxanide in combination with standard of care therapy in U.S.patients with chronic hepatitis C genotype 1 who have previously failed torespond to the standard of care therapy (peginterferon and ribavirin). Thecompany expects to announce interim data results at a medical meeting thisfall. Romark recently announced the initiation of a Phase II trial ofnitazoxanide in treatment-naive patients with chronic hepatitis C infectedwith genotype 1 (STEALTH C-3).
"Completing enrollment in this Phase II trial is a significant achievementfor Romark and an important step in the clinical development of nitazoxanide,"stated Marc Ayers, Chief Executive Officer of Romark. "We believe nitazoxaniderepresents a promising approach to the treatment of hepatitis C for themillions of people who are infected with this serious liver disease."
The study, called STEALTH C-2 (Studies to Evaluate Alinia for Treatment ofHepatitis C), is the second in a series of clinical trials designed toevaluate the safety and efficacy of nitazoxanide tablets in combination withPegasys(R) (peginterferon alfa-2a) or peginterferon and Copegus(R) (ribavirin)in patients with chronic hepatitis C. STEALTH C-2 is a randomized,double-blind, placebo-controlled trial conducted in the United States in 60patients with chronic hepatitis C genotype 1, who are non-responders to priorpeginterferon and ribavirin therapy. The study is designed to evaluate theeffectiveness and safety of nitazoxanide administered 500 mg twice daily forfour weeks followed by nitazoxanide plus Pegasys plus Copegus combinationtherapy for 48 weeks, compared to placebo for four weeks followed by placeboplus Pegasys plus Copegus combination therapy for 48 weeks. Pegasys andCopegus are being provided under a collaborative agreement between Romark andF. Hoffmann-La Roche Ltd.
Romark recently announced enrollment for its STEALTH C-3 clinical trial, aPhase II randomized, double-blind, placebo-controlled study designed toevaluate the safety and efficacy of nitazoxanide in combination withpeginterferon alfa-2a and ribavirin in treatment na´ve patients with chronichepatitis C infected with genotype 1. Enrollment for the STEALTH C-3 studybegan in April 2008 and the trial will enroll 60 patients at 15 centers in theU.S.
The primary objective of STEALTH C-3 is to evaluate sustained virologicresponse (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-intherapy followed by 48 weeks of standard of care plus nitazoxanide versus 4weeks of placebo lead-in followed by 48 weeks of standard of care and placebo.
Nitazoxanide belongs to a new class of small molecule kinase activatorscalled the thiazolides. Like interferons, thiazolides modulate cell signalingpathways involved in the host cell's innate defense against viruses.Thiazolides can be administered orally and are not associated with sideeffects commonly associated with use of interferon. Nitazoxanide wasdiscovered by Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief ScienceOfficer of Romark, and was initially developed by Romark and approved formarketing in the United States as a treatment for cryptosporidiosis. Recentlaboratory studies have shown that nitazoxanide does not induce resistancemediated by mutations in the viral genome.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease that is caused by thehepatitis C virus (HCV). It is the most common cause of chronic hepatitis inthe U.S. and may eventually lead to cirrhosis, liver cancer and liver failure.The disease is transmitted by contact with HCV-infected blood. A largemajority of those infected do not show symptoms, but fatigue, abdominal