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Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
Date:5/21/2008

TAMPA, Fla., May 21 /PRNewswire/ -- Romark Laboratories, L.C., a privately-owned biopharmaceutical company, today announced the completion of enrollment into its Phase II clinical trial to evaluate the safety and efficacy of nitazoxanide in combination with standard of care therapy in U.S. patients with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care therapy (peginterferon and ribavirin). The company expects to announce interim data results at a medical meeting this fall. Romark recently announced the initiation of a Phase II trial of nitazoxanide in treatment-naive patients with chronic hepatitis C infected with genotype 1 (STEALTH C-3).

"Completing enrollment in this Phase II trial is a significant achievement for Romark and an important step in the clinical development of nitazoxanide," stated Marc Ayers, Chief Executive Officer of Romark. "We believe nitazoxanide represents a promising approach to the treatment of hepatitis C for the millions of people who are infected with this serious liver disease."

The study, called STEALTH C-2 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is the second in a series of clinical trials designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with Pegasys(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 60 patients with chronic hepatitis C genotype 1, who are non-responders to prior peginterferon and ribavirin therapy. The study is designed to evaluate the effectiveness and safety of nitazoxanide administered 500 mg twice daily for four weeks followed by nitazoxanide plus Pegasys plus Copegus combination therapy for 48 weeks, compared to placebo for four weeks followed by placebo plus Pegasys plus Copegus combination therapy for 48 weeks. Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.

Romark recently announced enrollment for its STEALTH C-3 clinical trial, a Phase II randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alfa-2a and ribavirin in treatment nave patients with chronic hepatitis C infected with genotype 1. Enrollment for the STEALTH C-3 study began in April 2008 and the trial will enroll 60 patients at 15 centers in the U.S.

The primary objective of STEALTH C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus 4 weeks of placebo lead-in followed by 48 weeks of standard of care and placebo.

About Nitazoxanide

Nitazoxanide belongs to a new class of small molecule kinase activators called the thiazolides. Like interferons, thiazolides modulate cell signaling pathways involved in the host cell's innate defense against viruses. Thiazolides can be administered orally and are not associated with side effects commonly associated with use of interferon. Nitazoxanide was discovered by Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark, and was initially developed by Romark and approved for marketing in the United States as a treatment for cryptosporidiosis. Recent laboratory studies have shown that nitazoxanide does not induce resistance mediated by mutations in the viral genome.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease that is caused by the hepatitis C virus (HCV). It is the most common cause of chronic hepatitis in the U.S. and may eventually lead to cirrhosis, liver cancer and liver failure. The disease is transmitted by contact with HCV-infected blood. A large majority of those infected do not show symptoms, but fatigue, abdominal pain and nausea may occur. The current standard treatment of care, peginterferon and ribavirin, is effective in about half of all patients treated. According to the Centers for Disease Control, HCV affects an estimated 4.1 million Americans.

About Romark Laboratories

Romark Laboratories (http://www.romark.com), a privately held biopharmaceutical company, has discovered and developed a new class of small molecule antivirals known as thiazolides. The Company is developing nitazoxanide, the first of the thiazolide class, for the treatment of chronic hepatitis C, and is developing other new thiazolides for treating viral diseases including chronic hepatitis B. Alinia(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of infections caused by Cryptosporidium or Giardia.

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SOURCE Romark Laboratories, L.C.
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