FDA funds UA’s valley fever trial

The Office of Orphan Product Development in the Food and Drug Administration has awarded more than $1 million to the University of Arizona’s Valley Fever Center for Excellence.

The grant will help fund Phase One and Phase Two clinical trials for nikkomycin Z, a promising investigational treatment for valley fever.

Additional support for the development of nikkomycin Z has come from the National Institutes of Health, the Critical Path Institute, UA’s BIO5 Institute and New York-based JT Tai & Company Foundation.

Many donations came from individuals, including animal lovers because valley fever also is a major problem for dogs and other pets. Valley fever is a disease of the lungs caused by the fungus coccidioidomycosis that is common in the southwestern United States and northwestern Mexico.

The three-year safety trial will involve 60 patients with primary valley fever pneumonia who have not been sick for more than 30 days prior to enrollment in the trial, says BIO5 member David Nix, an associate professor in the UA College of Pharmacy.

His responsibilities for the clinical trial include drug handling, some of the laboratory analyses, data management, safety reporting and data analysis.

BIO5 member Susan Hoover, MD. and UA College of Medicine assistant professor, is responsible for evaluating and treating patients enrolled in the study.

The team is ready to enroll patients, who will be referred by the physicians who diagnose them with valley fever.

“At least nine UA departments and six sources of funding are involved thus far in moving nikkomycin Z forward,” says John Galgiani, MD, a BIO5 member and director of the Valley Fever Center for Excellence in the College of Medicine and Southern Arizona VA Healthcare System.

“But getting nikkomycin Z into the hands of patients with valley fever will likely require $40 to $60 million more than has been raised to date.”

The first clinical trial is just the beginning of a much longer process that includes running additional clinical trials, developing a less expensive process for producing the drug, simplifying the purification process and scaling up the manufacturing of the drug to make large quantities.

The 1983 Orphan Drug Act allows the federal government to assist in the development of treatments for rare (orphan) diseases, which according to the FDA, are diseases that affect fewer than 200,000 people a year.

Though rare in the rest of the nation, valley fever is a serious health problem in the Southwest. There are approximately 150,000 new infections each year, 100,000 of which are in Arizona.

Valley fever is an infection caused by inhaling fungal spores found in desert soil. Most individuals contract a lung infection that is self-limiting without treatment.

Symptoms range from very mild to pronounced enough to interfere with daily activities for weeks to months. A small percentage of cases are serious and often involve body sites other than lungs.

With currently available treatments, some patients require many years of treatment or even life-long therapy just to suppress the infection.

In 2006, 5,494 cases of valley fever were reported in Arizona, a 45 percent increase from the 3,772 cases in 2005. The number of reported cases is a fraction of total cases, since most are not recognized.

Results from experimental studies in animal models show that the valley fever fungus can be eradicated with the drug nikkomycin Z.

“This offers hope that nikkomycin Z might be curative in people,” says Galgiani. “The anti-fungal drugs now used help the immune system control the disease, but do not kill the fungus.”

The Valley Fever Center for Excellence is jointly sponsored by The University of Arizona and the Southern Arizona VA Healthcare System. For more information about Valley Fever: (520) 629-4777, (800) 470-8262, and vfever@email.arizona.edu. www.vfce.arizona.edu.

rford@gvnews.com