APT Pharmaceuticals, a specialty drug development company focused on the development of inhaled cyclosporine, announced that it has completed enrollment in its Phase III CYCLIST trial. The multi-center, randomized, controlled study enrolled 288 recent lung transplant recipients across 19 leading centers in North America, including the Cleveland Clinic; the University of Pittsburgh; and the University of California, San Francisco.
The objective of the CYCLIST trial is to evaluate the safety and efficacy of cyclosporine inhalation solution in improving bronchiolitis obliterans syndrome (BOS)-free survival following lung transplantation. Lung transplantation is a life-saving procedure for people with end-stage lung diseases who have exhausted all other available treatment options. However, average survival post-lung transplant is less than five years — significantly less than all other forms of solid organ transplant. Poor long-term outcomes in lung transplant patients appear to relate to BOS, a manifestation of chronic rejection, which remains a persistent problem despite administration of multi-drug systemic immunosuppressive regimens.
“We appreciate the broad support provided by the community of lung transplant centers, advocacy groups, patients and caregivers,” said Dr. Charlie Johnson, chief medical officer of APT Pharmaceuticals. “They have exceeded our expectations by enrolling this trial in just over a year.”
Date: February 24, 2010
Source: APT Pharmaceuticals
Filed Under: Drug Discovery