Valley Fever Drug Receives Fast-Track Designation by the FDA

The University of Arizona’s request to designate the antifungal drug nikkomycin Z (NikZ) as a “qualifying infectious disease product” (QIDP) has been granted; clinical trial to begin in late 2015. In observance of Valley Fever Awareness Week 2014, free events for the public and health professionals will be held in Tucson and Phoenix.

A potentially curative anti-Valley Fever drug has been given a boost in its development by the U.S. Food and Drug Administration.

The University of Arizona has received word that its request has been granted to designate nikkomycin Z (NikZ) as a “qualifying infectious disease product” (QIDP). NikZ is an antifungal drug that the UA has been helping to move into clinical trials and eventually to help patients. The UA has licensed development rights to Valley Fever Solutions, Inc. (VFS), a small start-up business in Tucson.

“Getting a QIDP designation is huge for our program,” said John Galgiani, MD, director of the UA Valley Fever Center for Excellence, project leader for the NikZ development team and chief medical officer for VFS. “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,” Dr. Galgiani explained. 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. Although Valley Fever is very common in Arizona, it almost never occurs outside the Southwest.

QIDP designation also provides access to priority review of marketing applications and eligibility for fast-track designation.

“This extended market exclusivity makes our Nikkomycin-Z effort much more attractive to investors, a major goal of the GAIN act,” said David Larwood, CEO of Valley Fever Solutions. “This brings us much closer to our dream of commercializing this promising compound.”

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

Between the UA and VFS, more than $12 million dollars has been raised in research grants from the National Institutes of Health, the FDA and from philanthropic donations, chiefly from the J.T. Tai & Company Foundation in New York City. Last month, VFS was awarded a $1.7 million small business grant from the NIH to resume clinical trials to treat Valley Fever pneumonia patients. The NIH also is helping to manufacture the NikZ that will be used in this clinical trial, scheduled to start in late 2015.

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Valley Fever Solutions, Inc., was founded in 2007 by David Larwood, president and CEO, in Tucson, Ariz. VFS seeks to develop new diagnostics, therapies and preventative vaccines for Valley Fever.

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 UA BIO5 Institute.

Valley Fever (Coccidioidomycosis) primarily is a disease of the lungs common in the Southwestern United States and Northwestern Mexico. It is 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.

Valley Fever Awareness Week 2014 Events

The Valley Fever Center for Excellence will host special free events in observance of Valley Fever Awareness Week 2014, Nov. 8-16. The events provide opportunities for the public and health professionals to hear experts and ask questions about Valley Fever.

• Valley Fever 101, a free event for the public, will be held Tuesday, Nov. 4, 9 to 11 a.m., at Banner Del E. Webb Medical Center, 14502 W. Meeker Blvd., Sun City West, and features presentations by:

  • Craig Rundbaken, DO, pulmonologist, Respiratory Valley Fever Clinic, Sun City West
  • Rebecca Sunenshine, MD, commander, U.S. Public Health Service; career epidemiology field officer, U.S. Centers for Disease Control and Prevention; medical director and administrator, Disease Control Division, Maricopa County Department of Public Health
  • John Galgiani, MD, director, UA Valley Fever Center for Excellence, and UA professor of medicine

• The Seventh Annual Public Forum on Valley Fever will be held Sunday, Nov. 9, 1 to 4 p.m., at the UA BIO5 Institute, Room 103, 1657 E. Helen St., Tucson. The free forum features UA experts:

  • Kenneth Ramos MD, PhD, PharmB, associate vice president for precision health sciences at the Arizona Health Sciences Center and professor of medicine in the UA Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine; “Precision Health: A Bold Initiative at the Arizona Health Sciences Center”
  • John Galgiani, MD, director, UA Valley Fever Center for Excellence, and UA professor of medicine; “Precision Health in Valley Fever, Does Ancestry Matter?”
  • Zaid Shehab, MD, professor of pediatrics and pathology and section chief, Division of Pediatric Infectious Diseases, UA Department of Pediatrics, “Valley Fever in Kids”
  • Lisa Shubitz, DVM, associate research professor, Department of Veterinary Science and Microbiology, UA School of Animal and Comparative Biomedical Sciences, “A Valley Fever Vaccine for Dogs”

Primary care medical providers are invited to attend a free conference, “Coccidioidomycosis (Valley Fever) for the Primary Care Physician,” Saturday, Nov. 8, 8 a.m. to noon, at Banner Good Samaritan Medical Center Amphitheater, 1111 E. McDowell, Phoenix. (CME credits are available.)

The scientific community is invited to the 19th Annual Farness Lecture, “Sarcoidosis: Using Genetics to find the Missing Antigen in the Granuloma,” with speaker Benjamin Rybicki, PhD, senior research epidemiologist, Henry Ford Health System, and head, Cancer Etiology Research Program, and associate director of research, Josephine Ford Cancer Center, Henry Ford Health System, Detroit, Mich.; Thursday, Nov. 20, Noon to 1 p.m., at the UA BIO5 Institute, Room 103, 1657 E. Helen St., Tucson.
To register for these events, or for more information, please visit the Valley Fever Center for Excellence website, www.vfce.arizona.edu