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Romark Laboratories Announces Presentation of New Nitazoxanide Data at 59th Annual AASLD Meeting and 50th Anniversary IASL Meeting in San Francisco
Date:10/28/2008

Company Also Announces Completion of Enrollment in U.S. Phase II Study of Nitazoxanide in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1

TAMPA, Fla., Oct. 28 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced the presentation of studies of nitazoxanide at the upcoming 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.

Nitazoxanide Abstracts

-- "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. 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)

-- "Potential Role for Nitazoxanide in Combination with STAT-C Agents

for the Inhibition of HCV Replication Without the Development of

Resistance," Korba, et al. Sunday Nov. 2, 5:30 PM PST (Oral Session

#115)

-- "Nitazoxanide (NTZ) is an Inducer of eIF2a and PKR

phosphorylation," Elazar et al., Tuesday, November 4, 8:00 AM -

12:30 PM PST (Poster #1881)

STEALTH C-3 Fully Enrolled

In addition, Romark announced it has completed enrollment of patients into its U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C genotype 1 (STEALTH C-3). The STEALTH C-3 (Studies to Evaluate Alinia for Treatment of Hepatitis C) study began enrollment in April 2008, and 112 patients were ultimately enrolled at 13 centers in the U.S. Data from a planned interim analysis is expected in early 2009.

A Phase II randomized, double-blind, placebo-controlled clinical trial, STEALTH C-3 is designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alfa-2a (Pegasys(R), Roche) and ribavirin (Copegus(R), Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1. The primary objective of this trial 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 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 can be common. 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
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