Romark Laboratories Announces Clinical Study Evaluating Alinia(R) for Treatment of Crohn's Disease
Posted on: Wednesday, 24 August 2005, 12:01 CDT
TAMPA, Fla., Aug. 24 /PRNewswire/ -- Romark Laboratories has begun enrolling patients in a clinical trial evaluating Alinia (nitazoxanide) for treatment of mild to moderate active Crohn's disease in adults.
The randomized, double-blind trial will compare the efficacy and safety of Alinia to that of a placebo. Alinia will be administered orally as a single 500 mg tablet two times per day. The study will be conducted in multiple centers in the United States.
"We believe nitazoxanide presents a unique and innovative approach to treating Crohn's disease," said Jean-Francois Rossignol, Chief Science Officer of Romark Laboratories. "In vitro studies have shown that the drug is active against a broad spectrum of anaerobic bacteria and that it inhibits the secretion of pro-inflammatory cytokines including TNF-alpha. Both of these mechanisms are believed to be important in managing Crohn's disease."
Crohn's disease is a chronic disease marked by an abnormal immune response that results in inflammation of the gastrointestinal tract. Researchers believe that the immune system mistakes microbes, such as bacteria that is normally found in the intestines, for foreign or invading substances, and launches an attack. In the process, the body sends white blood cells into the lining of the intestines, where they produce chronic inflammation. These cells then generate harmful products that ultimately lead to bowel injury.
"This is another important milestone for our company," said Romark's President and Chief Executive Officer, Marc Ayers. "It underscores our commitment to delivering innovation in the field of gastroenterology through the ongoing clinical development of Alinia."
Persons interested in participating in the clinical trial should contact Romark's Medical Affairs Department (by e-mail at medical.affairs@romark.com or by telephone at 813-282-8544).
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo. Alinia is under development in the United States for treatment of Clostridium difficile-associated diarrhea and Crohn's disease.
About Romark Laboratories
Romark Laboratories ( http://www.romark.com/ ) is a pharmaceutical company dedicated to the discovery, development and commercialization of innovative new first-in-class and best-in-class pharmaceutical products. Headquartered in Tampa, Florida, Romark conducts research and commercializes its products in the United States and in international markets.
Romark Laboratories
CONTACT: Elizabeth Freid, Hill & Knowlton Public Relations,+1-813-775-6206, for Romark Laboratories
Web site: http://www.romark.com/
Source: PRNewswire
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