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Romark Laboratories Initiates Phase-2 Study of Nitazoxanide in Treatment-Naive HCV

[This drug, which goes by the brand name Alinia, is FDA approved to treat diarrhea caused by parasites and only recently emerged as a possible therapy for HCV. This is the first study of this agent in treatment-naïve HCV patients; other phase-2 studies have been run in treatment-experienced genotype-4 and in treatment-experienced genotype-1.]

http://biz.yahoo.com/prnews/080418/nyf008.html?.v=101

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Friday April 18, 7:00 am ET

Trial Marks Third Study in Company's STEALTH C Clinical Program to Evaluate Nitazoxanide in the Treatment of Chronic Hepatitis C

TAMPA, Fla., April 18 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that it has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008.

The study, STEALTH C-3 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is a Phase II randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alpha-2a (Pegasys®, Roche) and ribavirin (Copegus®, Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1.

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. The trial will enroll 60 patients at 15 centers in the U.S.

"Earlier clinical studies in patients with chronic hepatitis C infected with genotype 4 have shown that nitazoxanide improves virologic response rates when used in combination with standard of care," said Dr. Emmet B. Keeffe, Chief Medical Officer of Romark. "This study and our ongoing STEALTH C-2 trial, are designed to evaluate the effect of treatment with nitazoxanide plus standard of care in patients with genotype 1. Future clinical trials will explore new combinations and treatment durations, including current and emerging HCV therapies."

STEALTH C Clinical Development Program

STEALTH C-3 is the latest in a series of clinical trials aimed at gaining a broad understanding of how nitazoxanide may benefit patients with chronic hepatitis C genotype 1 when used in combination with peginterferon and ribavirin. Other studies in the STEALTH C program include the following:

-- STEALTH C-2, a randomized, double-blind, placebo-controlled trial currently enrolling up to 60 patients in the U.S. with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care with peginterferon and ribavirin. This trial is designed to evaluate the effectiveness and safety of nitazoxanide administered 500 mg twice daily for 4 weeks followed by nitazoxanide plus standard of care for 48 weeks compared to placebo for 4 weeks followed by standard of care plus placebo for 48 weeks.

-- STEALTH C-1, an international study in 120 treatment-naive and interferon-experienced patients with chronic hepatitis C genotype 4. Interim results from the randomized controlled Phase II clinical trial were presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA and demonstrated that 79 percent of interferon-naive patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained viral response (SVR) at 12 weeks following treatment, compared to 43 percent of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Final study results (SVR-24) will be presented at the European Association for the Study of the Liver (EASL) in April 2008.

About Romark Laboratories

Romark Laboratories (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® (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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