Romark Laboratories to Develop Alinia as New Treatment for Chronic Hepatitis C

TAMPA, Fla. -- Romark Laboratories announced that it is initiating U.S. clinical development of Alinia (nitazoxanide) tablets for treating chronic hepatitis C.

The company has filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) and plans to seek fast-track designation for treating chronic hepatitis C. The initial clinical study in the United States will evaluate Alinia administered orally 500 mg twice daily for 24 weeks as monotherapy compared to a placebo in patients who have previously failed pegylated interferon and ribavirin combination therapy.

An estimated 3.4 million people in the U.S. are infected by hepatitis C virus. Globally, an estimated 170 million people are chronically infected, with 3 million to 4 million new cases reported each year, according to the World Health Organization. Some patients can be successfully treated with interferon-based treatment regimens, but safety and tolerability issues and suboptimal response rates leave a large number of patients without an effective treatment option.

Alinia (nitazoxanide) is the first of a new class of drugs called the thiazolides. Members of this class of drugs are small molecules that suppress replication of certain viruses by selectively inhibiting synthesis of virus structural proteins. Studies have shown that nitazoxanide and its circulating metabolite, tizoxanide, suppress replication of hepatitis B and C viruses in cell culture at low (nanomolar to low micromolar) concentrations.

A phase II, double-blind, placebo-controlled clinical trial of Alinia as oral monotherapy in patients with chronic hepatitis C was initiated in early 2005 at the Romark Digestive Disease Research Center in Egypt. The patients were infected with HCV genotype 4. Approximately 10 percent of the patients had previously failed pegylated interferon and ribavirin combination therapy.

An interim analysis of the first 20 patients enrolled in the study showed that 50 percent of patients receiving Alinia administered orally as one 500 mg tablet twice daily with food had undetectable HCV RNA in serum at the end of 24 weeks of treatment compared to none of the patients in the placebo group (P=0.03). Importantly, the drug has been well tolerated by the patients with no significant side effects. The study is continuing with patients being followed up to evaluate the durability of response off-treatment. Ongoing international studies are also evaluating Alinia in combination with pegylated interferon.

Results of preclinical and clinical studies are expected to be presented in medical journals and congresses later this year.

"This is an exciting development program," said Jean-Francois Rossignol, MD, PhD, chairman and chief science officer of Romark and the inventor of nitazoxanide and other thiazolides. "There is a tremendous need for a new treatment of chronic hepatitis C. Our results to date are encouraging, and we look forward to expanding our knowledge with the launch of clinical trials in the U.S."

"It is important that the mechanism of action of this class of drugs against hepatitis C virus is novel and differs from that of interferon and other traditional antiviral drugs," added Rossignol.  "Further study will be needed to fully understand the implications of this unique mechanism of action, but potential benefits may include synergistic effects with other antiviral drugs and reduced risk of developing drug-resistant viruses."

Alinia is approved for marketing in the United States for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia and is under development for treating Clostridium difficile-associated disease and Crohn's disease, in addition to chronic hepatitis C.

Source: Romark Laboratories