Date: Apr 30, 2006 Author: Angela Gonzales Source: bizjournals (
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ucson scientists are putting the finishing touches together on a spin-out company from the University of Arizona to develop a drug for valley fever.
Valley Fever Therapies LLC will be the name of the new company created to tackle the lung disease that infects about 150,000 people a year, with the majority living in Arizona.
Because it is not economically beneficial for large pharmaceutical firms to create a drug to treat a small number of people, there have been no drugs created to kill the fungus, said Dr. John Galgiani, director of the UA Valley Fever Center for Excellence and a faculty member of UA's BIO5 Institute.
The Critical Path Institute, or C-Path, is working with UA scientists to look for potential pharmaceutical partners.
"We're going to need partners," Galgiani said. "Some of those partners may move some of their work here."
Creation of this new company could spur big pharma to develop a presence in Arizona, which is good for the state's economy, he said.
"We hope as we develop the drug, it will be of economic benefit to the state as well," he said.
Tucson-based C-Path also helped UA scientists receive Orphan Drug Status from the U.S. Food and Drug Administration, which would allow scientists to apply for grants to help pay for the development of the drug. Under the 1983 Orphan Drug Act, the federal government can provide funding and assist researchers in developing treatments for rare diseases. They're called "orphan drugs" because large pharmaceutical companies turn their backs on what could be a money-losing proposition, Galgiani said.
The drug they hope to take to market is called Nikkomycin z, which the California State University Bakersfield Foundation for Research transferred to UA.
"No money was transferred," Galgiani said. "If the drug is developed, the foundation would get money out of it."
In the 1970s, a California scientist tested the drug on mice infected with valley fever, but there wasn't a big enough market for his company to pursue manufacturing it, Galgiani said.
The new drug works by blocking an enzyme the fungus needs to make the cell wall, he said. It is too soon to say whether the drug would be expensive once it is sold on the market.
"It will depend on how it's funded," Galgiani said. "If we develop this drug completely on charitable contributions, then there wouldn't be all these bills that need to be paid."
Galgiani has been busy writing $1 million worth of grant applications to the FDA and the National Institutes of Health to help finance clinical trials. He also plans to seek $1.8 million in funds from foundations, private investors and the state of Arizona.
That money would last a couple of years.
"At that point, the game gets a little more real," Galgiani said. "We expect we would need $20 million to $60 million to finish the job."
That's when they would need a pharmaceutical company to step in or seek state funding to take the drug to market.
"It could be that the partner could be the state of Arizona because they might think this is an important enough public health issue," Galgiani said.
Half of all of those affected by valley fever in the U.S. are in Maricopa County. Two-thirds are in Arizona, Galgiani said.
Fungus in the soil, especially during a dry, windy season, becomes airborne and settles in the lungs to cause the disease, Galgiani said. About 24 people die each year from the respiratory ailment, which can last several weeks to many months.
Dr. Ellen Feigal, director of medical devices and imaging for C-Path, said there is a bigger impact in working with BIO5 Institute on the drug.
C-Path's mission is to work with the FDA and large pharmaceutical companies to develop different ways to test drugs more quickly and effectively during clinical trials.
"This could become a model and potential template to assist and accelerate drugs for rare diseases," she said.
Many times, people don't even know they have the disease, said Dr. Raymond Woosley, president and chief executive of C-Path.
"Tens of thousands of people miss work, end up needing to see a doctor to get X-rays," he said. "There is no drug to treat those people today."
