Nitazoxanide (Alinia) could overcome drug-resistance in influenza, says Romark

Romark will soon begin Phase I clinical trials to test the anti-influenza virus activities of nitazoxanide, a medication currently used tin the treatment of diarrhea caused by giardia.

Nitazoxanide, which belongs to a new class of anti-influenza drugs called thiazolides with unique mechanism of action that targets maturation of viral hemagglutinin, can be useful in treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain, Romark said.

The nitazoxanide clinical trial is being conducted in approximately 25 sites across the United States and is expected to enroll 440 adult patients with acute uncomplicated influenza.

The trial will test the efficacy of oral nitazoxanide administered 500 mg twice daily for 5 days in reducing the  duration of symptoms of influenza.

Nitazoxanide (Alinia) and other drugs from thiazolides class inhibit the replication of influenza A viruses including H1N1 and H5N9 (a low pathogenicity avian strain) and influenza B virus in laboratory studies by a novel mechanism.

“This drug [nitazoxanide] works differently than the drugs we currently use for treating influenza,” said Professor M. Gabriella Santoro, Ph.D., Head of Virology Laboratory, Department of Biology at the University of Rome Tor Vergata in Rome, Italy and senior author of the article in the Journal of Biological Chemistry.

Nitazoxanide targets the maturation and intracellular transport of the viral hemagglutinin protein (HA), while Tamiflu (oseltamivir) and Relenza (zanamivir) target the neuraminidase protein (NA), and older drugs target the M2 protein. This unique mechanism is potentially very important in the setting of resistance or the threat of resistance to existing drugs.

The emergence of highly contagious and perhaps more pathogenic strains of influenza A virus represents a serious threat to global human health.  Efforts to control emerging influenza strains focus on surveillance and early diagnosis, as well as the development of vaccines and new antiviral drugs.

Romark is also developing nitazoxanide for treating a broad range of patients with chronic hepatitis C.

Phase 2 clinical trials of nitazoxanide in combination with peginterferon or peginterferon plus ribavirin have either been completed or are ongoing in treatment-naive and treatment-experienced patients infected with HCV genotypes 1 and 4 and in patients co-infected with HCV and HIV.

Data from ongoing studies will be reported at medical conferences during the first half of this year.

Studies in genotypes 2 and 3 chronic hepatitis C patients and other novel combination trials are in planning stages.  The company expects to begin phase 3 clinical trials of nitazoxanide in combination with peginterferon with or without ribavirin during 2010.

Alinia (nitazoxanide) for Oral Suspension (patients 1 year and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

What is influenza?

Influenza is a highly contagious acute respiratory illness caused by influenza viruses including the new H1N1 influenza.  Common symptoms include fever, runny nose, nasal congestion, sneezing, cough, sore throat, headache, muscle aches, sweats, chills and fatigue. Influenza illness affects all age groups and can lead to complications including sinusitis, otitis, bronchitis, pneumonia and central nervous system disease. In the United States, influenza is responsible for approximately 36,000 deaths and 216,000 hospitalizations per year.

Romark Laboratories, L.C is a biopharmaceutical company developing innovative new small molecules for treating infectious diseases and cancers.