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New research demonstrates potential diagnosis, treatment benefits
Date:1/10/2008

by Drs. Elahna Paul and Elizabeth Thiele of Massachusetts General Hospital in Boston, expresses enthusiasm and caution in the interpretation of the sirolimus research.

Sirolimus Study

The Phase I/II open-label study enrolled 25 patients with either LAM or TSC and angiomyolipomas. Sirolimus was administered to 20 patients for 12 months; 18 patients were followed 12 months after treatment was stopped. Researchers observed a 50 percent reduction in the primary endpoint angiomyolipoma volume at 12 months.

Secondary endpoints included average tumor size at 24 months and spirometric measurements of lung function. Angiomyolipoma volume increased to 85 percent of baseline at 24 months. In 11 patients with LAM, 12 months of sirolimus treat resulted in a 10 to 15 percent improvement in lung function. Researchers said improved pulmonary function was likely caused by a reduction of gas trapping in the lungs and a decrease in airflow obstruction.

Disease manifestations in the lungs, skin, brain and kidneys were also observed as these organs are affected by both diseases. The study was a non-randomized, open label proof of concept trial to lay the groundwork for larger trials to address questions about the safety and effect of sirolimus in LAM and TSC patients.

Our patients suffer tremendously from their disease, said John Bissler, M.D., lead author of the study and Physician-Scientist at Cincinnati Childrens Hospital Medical Center and the Cell and Cancer Biology Program at the University of Cincinnati College of Medicine. We currently treat their severe renal and pulmonary disease with surgery and organ transplantation. We hope that our results and additional research with sirolimus and other drugs will lead to specific targeted therapies that minimize the need for such surgeries.

Were encouraged to see progress with diseases for which there were no new therapies on the horizon, said Frank McCormack, M.D.
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Contact: Shellie Byrum
sbyrum@spectrumscience.com
202-955-6222 x2516
The LAM Foundation
Source:Eurekalert

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