MILAN, Italy, April 23 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that data from studies of nitazoxanide in chronic hepatitis C virus (HCV) infection are being communicated in four presentations made at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), held in Milan, Italy this week.
“These new studies confirm earlier data suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained virologic response in a limited number of genotype 1 patients,” said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and discoverer of nitazoxanide. “These data also provide interesting insights into the mechanism of action of nitazoxanide and confirm previous findings related to its safety.”
“These data show that the nitazoxanide lead-in phase prior to standard of care treatment can be reduced from 12 to 4 weeks with no apparent impact on virologic response rates,” said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and lead author of the study.
“The study demonstrated the safety of long-term nitazoxanide exposure in patients with chronic hepatitis C. Importantly, this data suggests that thiazolides have an interferon-like mechanism and as a class may have a role as single agent therapy in some patients,” said Dr. Emmet Keeffe, chief medical officer for Romark and co-author of the study.
“Data presented in each of these communications has provided important information in guiding the ongoing clinical development of nitazoxanide,” said Dr. Rossignol.
Romark is currently enrolling patients for two U.S. clinical trials studying nitazoxanide for the treatment of hepatitis C genotype 1. For more information please visit please visit www.romarktrials.com or www.clinicaltrials.gov and enter the search term “nitazoxanide hepatitis United States.”
About Nitazoxanide
Nitazoxanide belongs to a new class of small molecule cell signaling modulators (CSMs) 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 of cryptosporidiosis.
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 (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 Cryptosporidium and Giardia infection.
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Web site: http://www.romark.com/
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