Data presented for the first time today at the 25th Annual Meeting and Scientific Session of the International Society for Heart and Lung Transplantation (ISHLT) show that cyclosporine inhalation solution (CyIS) significantly improves long-term survival in lung-transplant patients compared to placebo. The data, which include 10-month follow-up statistics on patients originally enrolled in the pivotal study of CyIS, show that, with a median total follow-up of 53.3 months, CyIS-treated patients demonstrated a continued survival advantage over placebo-treated patients. Treatment with CyIS was associated with a 69 percent decrease in risk of death compared to placebo.

"Analysis of the pivotal study presented at ISHLT last year indicated that CyIS prevents chronic rejection, the most common cause of death in lung-transplant recipients. These follow-up data indicate that the significant survival advantage of CyIS compared to placebo persists long-term," said Aldo Iacono, M.D., lead investigator of the study and Medical Director of the Lung Transplantation Program at University of Maryland Medical Center, Associate Professor of Medicine at the University of Maryland School of Medicine. "Despite the medical community's best efforts, currently available immunosuppressive regimens have not been effective in reducing the incidence of chronic rejection or prolonging survival in lung-transplant patients. CyIS could be a breakthrough therapy to address this unmet need."

The randomized double-blinded, placebo-controlled pivotal study of CyIS was conducted at the University of Pittsburgh School of Medicine. The study began in 1998 and enrolled both single- and double-lung transplant patients who were already on standard, oral immunosuppressive therapies. Enrollment was completed in August 2001, and all subjects were followed until study completion in August 2003. Patients received either CyIS (n=26) or placebo (n=30), in addition to maintenance immunosuppression, a
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Contact: Lauren Mason
lmason@masonpr.com
210-857-2521
International Society for Heart and Lung Transplantation
8-Apr-2005

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