Full transcript with Valley Fever drug expert

An abbreviated Q & A with Galgiani appeared in a story in Monday's Arizona Daily Star about the anti-fungal drug nikkomycin Z (NikZ), which has been fast-tracked to treat Valley Fever.

NikZ is the first of a new class of anti-fungal drugs that attack the formation of “chitin,” a major component of the fungal cell wall.

Given to mice with the valley fever fungus, NikZ seemed to cure the infection.

The drug’s development was started in the 1990s by a small company in California but halted when the business failed. The NikZ program was inactive until it was acquired by the UA in 2005.

Here's what Galgiani told us about NikZ:

The FDA recently decided to designate NikZ as a "qualifying infectious disease product” - what does that mean for efforts to find a cure for Valley Fever?

Qualifying infectious disease product (QIDP) is a designation created by Congressional Legislation in 2012. This defines criteria for what sort anti-infective drug can be designated a QIDP. We applied for that and received that designation in July of this year.

QIDP designation is very important for the development of nikkomycin Z.

The drug was discovered in the 1970s and patents surrounding its discovery are now largely expired.

The QIDP designation confers five years of “market exclusivity” from the date that the drug goes on the market.

This is in addition to seven years of market exclusivity that nikkomycin Z obtained because it received "orphan drug”"designation in 2006. The combined 12 years of market exclusivity means that a company is protected from competitor companies for this 12 years of commercial activity which is what patents do.

Without this protection, it would be impossible to attract an investment partner to help the University of Arizona commercially develop nikkomycin Z.

QIDP also affords "fast-track" processing of applications. This means that the FDA will act quickly on applications we send them. That said, we still need to do the testing of nikkomycin Z in humans before the FDA has something to look at.

2. There's a clinical trial scheduled to start for NikZ in 2015. How will that trial work and are you looking for volunteers to be study subjects?

There is a clinical trial scheduled for the fall of 2015. It is designed to enroll patients with very early valley fever pneumonia and start treatment early before complications have arisen.

The purpose of the study is to determine if early treatment makes subjects feel better more quickly than non-treated subjects. We hope to enroll 48 subjects, 32 to receive nikkomycin Z and 16 to receive placebo.

3. Is NikZ expected to work on dogs, since they also are affected by Valley Fever?

Yes. Their problem is very similar to humans. If nikkomycin Z was approved for human use, veterinarians would be able to also prescribe it for dogs.

4. Is this the only Valley Fever treatment in development?

Yes.

5. Why do some people get serious cases and others do not?

Most of the differences (we believe) are genetic differences and we are now recruiting subjects to study what genetic differences may be involved.

6. Are all Arizonans vulnerable to getting Valley Fever, or are some more susceptible than others?

There is no differences between people in the risk of infection. The differences are related to how severe the infection is (see discussion of #5). Most patients probably are infected because they live here. A small number of infections are linked to particular activities that expose them to unusual exposures to spores (archeology, construction, etc.).

7. NikZ focuses on treatment and cure - but is there a way to prevent Valley Fever?

There is no way to prevent Valley Fever at present. We have had a long interest in finding a preventative vaccine and recently we have identified a possible vaccine candidate that might do this AND be inexpensive enough to produce. We are at the point of discovery here and getting this idea into clinical trials is only now being formulated.

8. State statistics show the number of Valley Fever cases dropped significantly between 2012 and 2013, and is still below the 2012 levels (less than 5,000 so far this year the state says and it was more than 10,000 per year for several years prior to 2013). Is there any explanation for the drop? Is Valley Fever perhaps decreasing in prevalence?

The best evidence for year-to-year changes comes from a UA climatology study that implicated rainfall as the driving factor. A recent Institute of Medicine article described this and emphasized that dust storms do not seem to play a significant role.

9. How will NikZ be administered - is it a pill?

Nikkomycin Z will be administered by mouth as a capsule.

10. How soon before you expect it to get to market?

Once we identify an investment partner, we should be able to seek approval within five years.

11. Anything else the public should know about Valley Fever?

Two-thirds of all Valley Fever infections occur in Arizona, mostly between Pima and Maricopa counties.

A third of all newly diagnosed pneumonias are due to the Valley Fever fungus. Economic impact to Arizona from medical care and lost productivity is on the order of $300 million annually.

Nationally, the Valley Fever Center for Excellence is the only such center focused exclusively on this one disease to improve our management of this major Arizona public health problem.