A federal agency granted $4.8 million to continue developing a vaccine that has shown promising results in preventing valley fever among dogs and could lead to a breakthrough for humans, Dr. John Galgiani, one of the nation’s leading valley fever researchers, said during a rare visit to Bakersfield Tuesday.
Galgiani, who runs the Valley Fever Center for Excellence at the University of Arizona, said he received the award notice last week from the National Institutes of Health to continue developing the vaccine, known as Delta-CPS-1, which has so far been lab-tested in mice.
The goal is to license the vaccine through the U.S. Drug Administration for dogs in the next four years, Galgiani said.
“If we could show that the vaccine is as effective and as safe as we think it will be for dogs, that will add to the momentum to getting it going forward to humans,” Galgiani said.
He stopped into town to help proclaim it Valley Fever Awareness Month after returning from an international, once-in-a-decade valley fever conference in the Bay Area.
Valley fever, or coccidioidomycosis, is a respiratory disease caused by inhaling microscopic fungal spores that live in loamy soil throughout the southwestern United States. The vast majority who breathe in the spores don’t develop symptoms, but others develop flu-like symptoms and an extreme fatigue that sometimes last months. In other cases, the spores spread into the bloodstream, leading to a host of health issues, including in rare cases death.
The multi-million dollar NIH grant comes just four years after Rep. Kevin McCarthy, R-Bakersfield, organized a national valley fever symposium that brought together leaders of the NIH and CDC to raise awareness of the orphan disease that is endemic to Kern County.
Galgiani credited McCarthy for that political mobilization, which he said has been slower to take shape in Arizona, where the disease infects roughly twice as many people annually.
During an address to the Kern County Board of Supervisors Tuesday and later during a meeting with members of the Bakersfield-based Valley Fever Americas Foundation, Galgiani described Bakersfield as a leading force in cocci research going back to the 1930s.
“I wish Arizona had as much focus on the disease as you do in Bakersfield," Galgiani told valley fever advocates. ...“It is literally the leader in awareness.”
And it was the California State University Bakersfield Foundation, Galgiani said, that rescued a potential valley fever cure, Nikkomycin Z, from being lost to a pharmaceutical company that went out of business mid-development.
The foundation purchased the manufactured drugs and transferred the responsibility of continuing development to the Valley Fever Center for Excellence, Galgiani said.
“It’s only happening because of Bakersfield,” Galgiani said.
So far, that drug has gone through one round of human clinical trials, where healthy adults without valley fever were given the drug for two weeks to see if there were any side effects. The trial showed no concern for toxicity or side effects, Galgiani said.
But after the trial, researchers ran into a problem – they ran out of Nikkomycin Z. Now they have no way to continue conducting more human clinical trials and eventually bring it to market, Galgiani said.
“We’re on the go-line. We think we’re 95 percent of the way there,” Galgiani said, adding that it would cost $1 million to $2 million to begin manufacturing the drug again, and an investment of roughly $50 million to bring it to market.
“We need industrial-strength investments to get it done,” Galgiani said.
Sandra Larson, a past president of the Valley Fever Americas Foundation, presented Galgiani with a $75,000 check — a far cry from what’s needed to start up human clinical trials again, but enough, she said, “to keep the doors open until we get the money we need.”