RESULTS FROM LUNG TRANSPLANT DRUG THERAPY TRIAL REVEAL EXPECTED BUT APPEALING FINDINGS
DONOR LUNG MANAGEMENT TRIAL (INSPIRE) UPDATE TO BE PRESENTED TODAY
PRAGUE, Czech Republic, April 20, 2012 – Results of a three-year international study of drug therapy for lung transplant patients will be presented today by Allan Glanville, M.D., Professor and Medical Director Lung Transplantation, Director Thoracic Medicine, at St. Vincent's Hospital in Darlinghurst, Australia, during the International Society for Heart and Lung Transplantation (ISHLT) 32nd Annual Meeting and Scientific Sessions in Prague, Czech Republic.
There are currently no therapies which prevent obliterative bronchiolitis after lung transplantation or its alternative, bronchiolitis obliterans syndrome (BOS). The CeMyLungs study looked at 165 lung transplant patients over a three-year period and the efficacy and safety of two available treatments: delayed onset Everolimus (Certican, RAD) with reduced target C2-monitored cyclosporin for BOS prevention compared with de novo mycophenolate sodium (Myfortic, MPS) with standard target cyclosporin.
Results indicate that both treatments offer equivalent efficacy in preventing BOS with a non significant difference in survival.
“Three year data on the 165 randomized patients showed a survival rate of 80 percent using the treatments but, appears neither drug prevents BOS, the rate being similar to other three year studies,” according to Dr. Glanville.
Dr. Glanville said that time to treatment failure was equal between the two drugs but patients spent longer on Myfortic which may have accounted for a higher side effect profile. He continued that the per protocol population had a shorter time to BOS in the Everolimus arm of the study, for reasons which were as yet unidentified. Dr. Glanville said further analysis is warranted in this area.
INSPIRE TRIAL UPDATE
The INSPIRE International Lung Trial with the Organ Care System Technology (OCS™) is a study of lung transplant patients that will be presented during Concurrent Session 34 at today’s ISHLT meeting.
The study is evaluating the clinical value of using the OCS™ lung device to preserve, recruit and assess the donor lungs for transplantation as compared to current cold storage technique.
Current cold storage methods include using a mixture of solutions pumped through the lungs and bringing the organ temperature down to between four and eight degrees Celsius (39.2 – 46.4 Fahrenheit). The ultimate goal is to keep damage to the removed organ at a minimum while awaiting transplant.
The INSPIRE trial is looking at patients 30-days after transplant and utilized the ISHLT Primary Graft Dysfunction (PGD) to grade potential post-transplant risk. An update from the study will be presented today with the trial completion set for 2013.
The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit professional organization with more than 2,700 members from over 45 countries dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. For more information, visit www.ishlt.org .
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Contact: Stephen Chavez