Valley fever aid may be on way

[Guest guest]

Valley fever aid may be on way

UA to seek FDA OK on drug

http://www.azcentral.com/arizonarepublic/local/articles/1217valleyfev

er.html

Larry Copenhaver

Tucson Citizen

Dec. 17, 2005 12:00 AM

The University of Arizona plans to seek FDA approval of a promising

treatment for valley fever, a lung disease common in the Southwest.

The drug, acquired by UA in May, may kill the potentially lethal

infection caused by a fungus that lives in the soil, said Dr.

Galgiani, director of the university's Valley Fever Center for

Excellence.

Valley fever is similar to mononucleosis, causing victims to feel

tired, lose weight, develop a chronic cough and a low-grade fever.

In severe cases, valley fever kills. advertisement

It is estimated that 150,000 people in the Southwest, from southwest

Texas to central California, are infected with the disease each

year. About 30,000 of those are Arizonans, Galgiani said.

One in three show symptoms, and about 10 percent of them require

treatment. Generally, fewer than 35 Arizonans die of the infection

each year, according to the Arizona Department of Health Services.

Patients diagnosed with valley fever typically are treated with anti-

fungal medication, but nothing on the market prevents or cures the

disease. UA's drug, nikkomycin z, might provide the best treatment

yet.

" One of the limitations of current treatment is that it does not

seem to cure the disease, " Galgiani said. " It helps people, and the

infection calms down. But it's an inhibitory effect, not a killing

effect, of the fungus. It's very common, that if you have this

disease, get treatment, get better and stop the treatment, you

relapse. "

Although researchers discovered the drug in the 1970s, tests were

halted for financial reasons, Galgiani said. No one was willing to

invest the hundreds of millions of dollars necessary to conduct the

extensive studies mandated by the U.S. Food and Drug Administration.

There are too few people infected with the disease for drug

companies to get their investment back.

Any disease that affects fewer than 200,000 a year is considered by

the FDA to be an orphan or rare disease and not considered a major

health risk. There are about 5,000 diseases classified as orphan

diseases.

" So you have a paradox, " Galgiani said. " One of the most common and

serious (health) problems in our state is considered an orphan

disease for the country. "

Galgiani believes studies to meet FDA requirements could cost

between $10 million and $100 million over a five- to seven-year

period.

To help with funding, Galgiani said he would work through a new

Tucson-based non-profit organization called the Critical Path

Institute, which seeks to bring safer drugs to market faster.

The fungus, known as Coccidioides immitis, that causes valley fever

is picked up in the respiratory system of humans and animals.

The fungus is typically found in areas with low rainfall, high

summer temperatures and moderate winter weather. When the soil is

disturbed, spores of the fungus can be inhaled.

People 65 and older are most at risk for the disease. African-

Americans, Filipinos, pregnant women in their third trimester and

those with weakened immune systems also face a greater risk.

The incidence rates in Arizona have soared over the past decade,

increasing to 57 people per 100,000 residents in 2002, according to

the state health department.

That compares with 11.5 people per 100,000 residents in 1992.

Reporter Kerry Fehr-Snyder contributed to this article.