Thanks to UA, Valley Fever Gains Respect
The University’s request to designate the antifungal drug nikkomycin Z as a “qualifying infectious disease product” has been granted, and a clinical trial will begin in late 2015.
You could say that valley fever is the Rodney Dangerfield of infectious diseases, and you wouldn't be far off.
It's not contagious, and it has presented itself mostly in three counties in southern Arizona and one in central California. The collective national concern: zzzzzz.
"People don't stop what they're doing to focus on this," Dr. John Galgiani, a UA professor of medicine and director of the Valley Fever Center for Excellence, told an audience Sunday at a public forum on valley fever held at the University of Arizona's BIO5 Institute. "But we care a lot about it."
Though slow in coming — this week marks the 12th iteration of Valley Fever Awareness Week — respect does seem to be growing. U.S. Rep. David Schweikert of Arizona's Sixth Congressional District, who was on hand at the forum, has been an ally in Washington, D.C., along with Rep. Kevin McCarthy of Bakersfield, Calif.
"Public awareness has gone up dramatically," Schweikert said.
Valley fever now has the attention of the Centers for Disease Control and Prevention and the National Institutes of Health, Galgiani noted. "It takes repetition and time to see that we ought to be doing something about this," he said. "It's going slower than any of us would like, but it's going in our direction."
Recently, the UA received word that its request had been granted to designate nikkomycin Z (NikZ) as a "qualifying infectious disease product," or QIDP. NikZ is an antifungal drug that the UA has been helping to move into clinical trials in 2015 and eventually to help patients. The UA has licensed development rights to Valley Fever Solutions Inc., a small startup business in Tucson.
"Getting a QIDP designation is huge for our program," Galgiani said. "It makes NikZ much more attractive to investors because of the added protection and other benefits that come with this designation."
QIDP designation is a key provision of the GAIN Act, approved by Congress in 2012 to increase the incentives for drug manufacturers to produce new antibiotics for serious and hard-to-treat bacterial and fungal infections. Valley fever (coccidioidomycosis) is one such infection that currently has no cure. QIDP designation for a drug adds an additional five years of market exclusivity, which means that the company that brings the drug into clinical use is protected from competitors for that period.
"This is especially valuable for NikZ development because it is an old drug and most of its patent protection already has expired," Galgiani said. This protection is on top of seven additional years of exclusivity that were granted to NikZ when it was designated an "orphan drug," or one that is used for a relatively uncommon disease such as valley fever.
Given to mice with the valley fever fungus, NikZ seems to cure the infection. The drug’s development was started in the 1990s by a small company in California but was halted when the business failed. The NikZ program was inactive until it was acquired by the UA in 2005 and clinical trials were restarted.
"The UA was willing to take on the NikZ project," Galgiani said. "It was seen as part of the mission of the University. ... There's a cost to doing nothing (about valley fever). This is a valid disease. It's an area where we in Arizona need to be pushing the envelope. It's our disease."
The UA Valley Fever Center for Excellence was established in 1996 by the Arizona Board of Regents for the benefit of the entire state. Based at the UA College of Medicine – Tucson, the center has developed a research base, including all three of the state’s universities and an information program for both the scientific community and the general public. Much of the center’s research is conducted at the BIO5 Institute.
Valley fever primarily is a disease of the lungs caused by the coccidioides species of fungus, which grows in soils in areas of low rainfall, high summer temperatures and moderate winter temperatures. The fungal spores become airborne when the soil is disturbed by winds, construction, farming and other activities. In susceptible people and animals, infection occurs when a spore is inhaled. An estimated 150,000 infections occur each year in the Southwest. Approximately one-third of these result in a self-limited, possibly lengthy, respiratory illness. However, in a small percentage the illness is more serious and potentially lethal.
Two-thirds of all U.S. infections occur in the Arizona counties of Maricopa, Pinal and Pima, making the UA "the only research institution in the hyperendemic areas," Galgiani said.
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