New clinical-trials studies, center signal state’s growing research capacity

October 11, 2007

By hammersmith

As its research infrastructure matures, Arizona is gradually expanding its capacity to conduct clinical trails of new drugs, medical devices, and procedures. The latest signals of the state’s progress include two clinical trials ready to kick off, plus the opening of a new clinical-trials center at Arizona State University.

One of the clinical-trials studies, which began recruiting participants in early September, is testing a new means for treating diabetics who suffer from cardiovascular disease.

The $25-million study, led by cardiologist Nabil Dib of Catholic Healthcare West and the Arizona Heart Institute, will enroll some 2,400 patients worldwide, including, during the first year of the five-year study, 12 to 20 patients at the Mercy Gilbert Medical Center and Chandler Regional Medical Center, the Business Journal of Phoenix reported.

Patients in the study, funded by the National Institutes of Health’s National Heart, Lung and Blood Institute, will be diabetics with arterial blockages that would typically call for invasive bypass surgery. While life-saving in many instances, such surgery has a high incidence of complications and a lengthy recovery time. Trial participants will instead undergo a less-risky outpatient angioplasty procedure that involves inserting drug-coated stents into blocked arteries.

Although the portion of trial participants in Arizona is small, the study is especially significant both for its bedside setting—indicative of the robust research capacity at non-university hospitals like Mercy Gilbert and Chandler Regional—and for Dr. Dib’s oversight of the investigation. Dr. Dibs received national media attention earlier this year for his leadership of a separate study, in which patients who have had heart attacks receive injections of stem cells sourced from their own bodies, with the goal of regrowing heart muscle.

A second clinical-trials study, led by three researchers from the University of Arizona’s BIO5 Institute, will tackle a less-prevalent disease with a high profile in Arizona: valley fever. A $1-million grant from the Food and Drug Administration to the UA’s Valley Fever Center of Excellence will allow the researchers to test the bacteria-derived drug nikkomycin Z.

Valley fever is a fungal pneumonia that produces potentially severe cold- or flu-like symptoms and each year afflicts around 100,000 people in the Tucson-Phoenix corridor, representing more than half of all valley-fever infections. UA owns the rights to the nikkomycin Z, which was discovered in the 1970s and has been shown to kill valley-fever spores in mice.

The lead investigators for the valley-fever study are John Galgiani, Susan Hoover, and David Nix, all researchers at BIO5, which is dedicated to collaborative study across five disciplines: science, agriculture, medicine, pharmacy, and engineering.

Around 60 patients will participate in the three-year study, which will concentrate on determining nikkomycin Z’s safety in humans; secondarily, the study will track the drug’s effectiveness in killing the fungus. The next set of trials, which would require additional funding, would seek to precisely calibrate dosages of the drug. Galgiani told the Tucson Citizen that bringing the nikkomycin Z to market could require an additional $40 million to $60 million.

Such daunting expenses highlight both the need for a broader base of risk-capital financing for biotech research and development, and the commercial potential in cost-effective management of such research.

Recognizing the statewide need for greater infrastructure and expertise to manage such complex and expensive clinical trials, ASU has established the Center for Healthcare Innovation & Clinical Trials. Directing the center will be nursing professor Linda Mottle, whose specialties include clinical research development.

Using the center’s resources, companies of all sizes will be able to conduct clinical trials of new drugs, devices, and procedures. Simultaneously, the center will offer a graduate certificate in clinical research management, an interdisciplinary master’s degree in clinical-trials management, and pre- and post-doctoral mentorship programs for research scientists.

The center, housed in the College of Nursing and Healthcare Innovation, draws on interdisciplinary partnerships across the university and constitutes one of the hallmark initiatives funded under a five-year, $5 million grant by the Ewing Marion Kauffman Foundation’s “University as Entrepreneur” program.

“This initiative advances the ASU entrepreneur initiative by launching an innovative center, which to our knowledge, is the first of its kind in the country,” Mottle said. “It will create a national hub for clinicians, scientists, and collaborating health care institutions and community partners to advance health care.”

Other private-sector companies in Arizona, such as Phoenix-based Dedicated Phase Inc. and Litchfield Park-based Dedicated Clinical Research Inc., already perform clinical-trials management, but they told the Business Journal that they believe the new ASU center will give a boost to the biotech industry, not crowd out other firms, partly because regulations will prohibit ASU from undercutting private-sector competitors.

“As one of the largest cities in the U.S., we’re not on the map yet,” said Jason Bonanza, president and CEO of Dedicated Phase I, in the Business Journal. “We need sites that can step up and meet the demand in the industry.”

For more information:

East Valley CHW hospitals kick off $25M diabetes study,” The Business Journal of Phoenix, 09/07/2007

Valley fever cure may be coming,” The Tucson Citizen, 09/13/2007

ASU nursing school starts clinical trials program,” The Business Journal of Phoenix, 09/21/2007

ASU news release, 09/25/2007