Study Showing Improved Virologic Response with Nitazoxanide in Chronic Hepatitis C Published in Gastroenterology

TAMPA, Fla., March 02, 2009 /PRNewswire/ -- A study evaluating nitazoxanide in combination with peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV) infection with genotype 4 was published in the March issue of the official journal of the American Gastroenterological Association Institute (AGA Institute). The study showed that the addition of nitazoxanide to standard-of-care therapy increased the rate of sustained virologic response when compared with patients given peginterferon plus ribavirin alone.(1) An accompanying editorial commenting on the study was also published in the Journal.(2)

"The results published today in represent an important milestone in the development of nitazoxanide, the first thiazolide, for the treatment of chronic hepatitis C," said Jean-Francois Rossignol, MD, PhD, Romark Institute for Medical Research, the inventor of this new class of antiviral drugs and lead author of the study. "Nitazoxanide is currently being evaluated along with the standard-of-care treatment in patients with chronic hepatitis C genotype 1 in clinical trials in the U.S., and we look forward to reporting interim data from those trials in the coming months."

The randomized, controlled study published in evaluated the safety and efficacy of nitazoxanide plus peginterferon, with or without ribavirin, in 97 patients with previously untreated genotype 4 chronic hepatitis C at 2 centers in Egypt. Participants were sequentially allocated into 3 treatment arms (one patient immediately dropped from the study):

The primary endpoint was sustained virological response (SVR), or serum HCV RNA <12 iu>

The percentages of patients with RVR, defined as undetectable serum HCV RNA at week 4 of combination therapy, and SVR were significantly higher in patients given the triple therapy compared with the standard of care (64% versus 38%, p=0.048 and 79% versus 50%, p=0.023, respectively). Patients given nitazoxanide plus peginterferon alfa-2a had intermediate rates of RVR (54%) and SVR (61%). Adverse events were similar across treatment groups except for a higher rate of anemia in the groups receiving ribavirin. In the nitazoxanide group, virologic responses were maintained through the end of treatment with no virologic breakthroughs. Of note, the use of nitazoxanide was associated with reduced relapse rates (3/20 patients in the peginterferon plus nitazoxanide arm, and 1/23 patients in the triple arm with peginterferon, ribavirin and nitazoxanide) versus 10/30 patients in the standard-of-care arm.

Nitazoxanide, the first of a new class of broad spectrum antiviral drugs known as the thiazolides, is undergoing worldwide development as a treatment of chronic hepatitis C. Nitazoxanide is a potent inhibitor of hepatitis C virus (HCV) replication in HCV genotype 1-derived replicon cell lines, and studies have shown that it does not induce mutations in the virus that confer resistance. Phase II clinical trials are ongoing in the United States in patients with chronic hepatitis C and genotype 1 infection.

A recent Phase II study of low and high doses of a controlled-release nitazoxanide tablet showed favorable pharmacokinetics and significant reduction in viral load, with good tolerability and safety.(3)Romark recently entered into an agreement granting Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, an exclusive license to develop and market nitazoxanide for the treatment of chronic hepatitis C in Japan.

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 has affected an estimated 4.1 million Americans.

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(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of infections caused by or .

(1)"Improved Virologic Response in Chronic Hepatitis C Genotype 4 Patients Given Nitazoxanide, Peginterferon and Ribavirin," J.F. Rossignol, M.D. et. al., Gastroenterology, Vol. 136 issue 3, pp 856-862, March 2009

(2)"Nitazoxanide: Beyond Parasites Toward a Novel Agent for Hepatitis C," Jama M. Darling, Michael W. Fried, Gastroenterology Vol. 136 issue 3, pp 760-763, March 2009

(3)"Controlled Release Tablet Improves Pharmacokinetics, Viral Kinetics and Tolerability of Nitazoxanide for Treatment of Chronic Hepatitis C," Emmet B. Keeffe, M.D., of the Romark Institute for Medical Research, Tampa, FL. 19th Conference of the Asian Pacific Association for the Study of the Liver (APASL), abstract FP052, February 14, 2009

CONTACT: Matthew J. Scampoli of BMC Communications Group, LLC,+1-212-477-9007 ext. 18, for Romark Laboratories

Web site: http://www.romark.com/

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Posted: March 2009

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