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New therapy found for rare lung disorder
Date:3/16/2011

ing lung function in women with LAM."

McCormack says LAM cells isolated from lung lesions have TSC mutations and exhibit activation of a key sirolimus-sensitive growth pathway. When exposed to the drug in culture, the growth of LAM cells is stopped.

Experiments in TSC animal models have also demonstrated that sirolimus shrinks tumors in the liver and kidneys.

The MILES study was conducted within the National Institutes of Health (NIH)-supported Rare Lung Diseases Consortium, led by UC and Cincinnati Children's physician and pulmonary biologist Bruce Trapnell, MD, and co-directed by McCormack, and involved 13 institutions from around the world. Data was reported using Internet-based systems connected to a centralized, Internet-based data coordinating center headed by Jeffrey Krischer, MD, at the University of South Florida, Tampa.

"The trial included a screening visit and a year-long double blind, placebo-controlled treatment period, followed by a year of observation," says McCormack.

All eligible participants were female, aged 18 years or older and had a confirmed diagnosis of LAM with abnormal lung function.

Patients meeting the criteria were randomly assigned to either receive an initial dose of oral sirolimus at 2 milligrams per day or a matched placebo, and sirolimus levels were measured at each follow-up visit. Results were revealed only to an independent medical monitor who made dosing recommendations to maintain serum levels within a pre-specified target range.

A total of 89 patients with LAM were enrolled in the United States, Canada and Japan. Patients underwent baseline lung function testing, and lung function and exercise outcomes were measured over the course of six visits in the first year. Participants were also given questionnaires to determine how their symptoms changed throughout the course of the study.

Researchers found that sirolimus stabilized lung function and was associ
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Contact: Katie Pence
katie.pence@uc.edu
513-558-4561
University of Cincinnati Academic Health Center
Source:Eurekalert

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