Study finds safe, effective treatment for diarrhea caused by Cryptosporidium parvum

TAMPA, Fla., July 2, 2001 — Scientists with the Romark Institute for Medical Research have identified the first treatment for diarrhea caused by the protozoan Cryptosporidium parvum.

As reported in the July 2001 issue of The Journal of Infectious Diseases, patients taking nitazoxanide were well within three to four days of initiating treatment.

In the first study of its kind, researchers analyzed the effects of two formulations of nitazoxanide against matching placebos in 100 patients (50 adults and adolescents, 50 children) from the Nile delta of Egypt. In the nitazoxanide control group, adults and adolescents received a 500 mg tablet and children received a 100 mg/5 ml strawberry-flavored oral suspension.

At a follow-up visit seven days after beginning the three-day treatment, 80 percent of the nitazoxanide treatment group were well compared to 41 percent of the placebo group. Nitazoxanide treatment reduced both the duration of diarrhea and oocyst shedding. Side effects were similar in both groups, proving the safety of the drug.

"The identification of a safe, effective treatment for diarrhea caused by Cryptosporidium parvum is significant," said Dr. Jean-Francois Rossignol, co- founder, chairman and chief science officer of Romark Laboratories. "The infection, transmitted by consuming contaminated water or food, can be particularly serious in children, elderly persons and people with weakened immune systems. The diarrhea often leads to dehydration, malnutrition, impaired physical development and even death."

Nitazoxanide is currently marketed in most of Latin America as a three-day treatment for a wide range of protozoan and helminth infections. Romark Laboratories is seeking approval to market nitazoxanide in the United States under the trade name Cryptaz™.

About Romark Laboratories

The Romark Institute for Medical Research was organized by Romark Laboratories, L.C. in 1994 to conduct pharmaceutical research in the fields of emerging infectious and parasitic diseases. Romark Laboratories is a privately owned, research-based pharmaceutical company based in Tampa, Fla., dedicated to the discovery and development of innovative new pharmaceutical products for treating infectious diseases. Learn more by visiting www.romarklabs.com.

SOURCE: Romark Laboratories, L.C.