One of the major challenges the researchers faced early on was finding a substance that could be mixed with the cyclosporine to enable patients to safely inhale the drug without irritating their throat or lungs. They decided to combine the cyclosporine with propylene glycol, which allowed the drug to be administered as an aerosol. Novartis Pharmaceuticals provided the cyclosporine powder, which was then compounded by the researchers.
The formula enabled patients to breathe in high doses of the anti-rejection drug without hurting other organs. Such high doses, if given orally, would have a toxic impact on the kidneys. About half of the people in the study, in both the cyclosporine and the placebo groups, experienced some respiratory irritation, but many developed a tolerance for the inhaled drug after a few treatments.
The University of Pittsburgh licensed its data on inhaled cyclosporine to Novartis in 2001. In April 2003, Chiron Corporation obtained rights to the data through an in-licensing agreement with Novartis. The inhaled drug has not been approved by the Food and Drug Administration, and therefore, is not yet available to lung transplant patients.
"My hope is that one day soon our patients will have access to this therapy," says Dr. Iacono. "As our study demonstrated, patients who took the inhaled cyclosporine had a substantially better chance of survival because they were free from chronic rejection," he adds.
In addition to Drs. Iacono and Griffith, other authors of the study include: from the University of Pittsburgh, Bruce A. Johnson, M.D.; Wayne F. Grgurich; J. Georges Youssef, M.D.; Timothy E. Corcoran, Ph.D.; Diedre A. Seiler
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Contact: Ellen Beth Levitt
eblevitt@umm.edu
410-328-8919
University of Maryland Medical Center
11-Jan-2006