TUCSON - Researchers at the University of Arizona are set to begin human clinical trials on a drug they hope will cure valley fever.
The drug Nikkomycin Z will be tested in Tucson on people newly diagnosed with the fungal infection to test the drug’s safety and effectiveness, said Dr. John Galgiani, director of the university’s Valley Fever Center for Excellence.
Valley fever — also known as coccidioidomycosis — primarily strikes people in desert areas of southern Arizona and the San Joaquin Valley in California, Galgiani said. But the fungus exists throughout the desert Southwest and northern Mexico.
Four drugs have been approved for treatment of valley fever, but none kills the fungus outright.
Nikkomycin Z, discovered in the 1970s, has been shown to kill the fungus in mice.
The fungal spores are found in soil and wind or construction can make them airborne. They are then inhaled by people, Galgiani said. The spores then change into larger structures called spherules, which grow and burst, and trigger new spherules.
An estimated 130,000 people are exposed each year, but only about 30,000 become sick enough to seek medical care. About 60 percent of the infections are in Arizonans living in Tucson, Phoenix and areas along Interstate 10, Galgiani said.
A moderate, uncomplicated case runs from weeks to months and includes a cough, chest pain, fever, weight loss, fatigue, bone and joint pains and skin rashes. Severe cases can be fatal.
Researchers hope the clinical trial will show that Nikkomycin Z will kill the fungus in humans.
The research group received $1 million from the U.S. Food and Drug Administration in August to fund the three-year clinical trial.
The primary focus is proving the safety of the drug, said University of Arizona researcher Dr. Susan Hoover.
Nikkomycin Z was discovered by Bayer AG while the company sought ways to suppress the growth of fungi in produce to avoid food spoilage. Medical applications were discovered in 1990, and California-based Shaman Pharmaceuticals obtained the drug in 1995.
The drug was purchased in 2001 by California State University, Bakersfield’s Foundation for Research.
The university purchased Nikkomycin Z in May 2005, and the Valley Fever Center for Excellence began efforts to raise funds to get clinical trials moving.
The team has enough of the drug to run the initial clinical tests, but will need about $2 million to manufacture more for full-scale human trials needed to obtain final FDA approval.
The National Institutes of Health donated $400,000 worth of lab work that verified the remaining drug was suitable for testing, he said. The institutes also donated $225,000 to fund planning for the initial trial, Galgiani said.
“It’s a priority project with NIH,” Galgiani said. “Valley fever is an unmet need. No drug cures the disease.”