Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Data show cyclosporine inhalation solution improves long-term survival in lung-transplant patients

11.04.2005


Inhaled therapy addresses most common cause of death among lung-transplant recipients



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, and underwent an initial 10-day dose escalation phase to reach a maximum tolerated dose, up to 300 mg. Following initiation, patients received a maintenance dose of either the CyIS or placebo three times per week for two years. Upon completion of dosing, all subjects were followed for efficacy, including chronic rejection and survival, until the last enrolled subject completed the two-year period of dosing.

Analysis of data from the initial study period showed a 79 percent decrease in the risk of death for patients receiving CyIS compared to patients receiving placebo. Data from an additional 10 months of follow-up show that the survival duration for CyIS-treated patients remained significantly higher versus placebo-treated patients (log-rank p=.017). Estimated four-year survival was 84 percent in CyIS-treated subjects compared to 56 percent in placebo-treated subjects. The estimated hazard ratio (CyIS/placebo) of 0.31 corresponds with a 69 percent reduction in mortality.

CyIS therapy delivers cyclosporine directly to the lungs, achieving greater drug concentration at the site of rejection. A New Drug Application (NDA) for CyIS (tradename PULMINIQTM) was submitted to the U.S. Food and Drug Administration (FDA) by Chiron Corporation in October 2004 and is now under review. Cyclosporine in other formulations is a well-established immunosuppressive therapy for kidney, liver and heart transplant recipients. Currently, there are no FDA-approved therapies for the prevention of chronic rejection.

Compared to other organ transplants, long-term survival following lung transplantation has not improved appreciably in the last 10 to 15 years. According to 2004 ISHLT registry data of lung transplants performed between January 1998 and June 2002, one-year survival remains about 75 percent. At five years, survival remains approximately 45 percent, essentially unchanged since the late 1980s and early 1990s, and is significantly lower than survival rates following other solid organ transplants.

About Lung Transplant Rejection

Following transplantation there is an inherent risk of rejection, where the recipient’s immune system will recognize the donated lungs as foreign and attack the transplanted organ. Within the first three months, patients are at highest risk of acute rejection. However, as the patient moves out in time, the primary cause of death in up to 76 percent of cases is chronic rejection, which usually manifests after the first year. This is characterized by chronic inflammation and irreversible scarring of the lungs, a condition known as bronchiolitis obliterans.

Lauren Mason | EurekAlert!
Further information:
http://www.ishlt.org

More articles from Health and Medicine:

nachricht Nanoparticles as a Solution against Antibiotic Resistance?
15.12.2017 | Friedrich-Schiller-Universität Jena

nachricht Plasmonic biosensors enable development of new easy-to-use health tests
14.12.2017 | Aalto University

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: First-of-its-kind chemical oscillator offers new level of molecular control

DNA molecules that follow specific instructions could offer more precise molecular control of synthetic chemical systems, a discovery that opens the door for engineers to create molecular machines with new and complex behaviors.

Researchers have created chemical amplifiers and a chemical oscillator using a systematic method that has the potential to embed sophisticated circuit...

Im Focus: Long-lived storage of a photonic qubit for worldwide teleportation

MPQ scientists achieve long storage times for photonic quantum bits which break the lower bound for direct teleportation in a global quantum network.

Concerning the development of quantum memories for the realization of global quantum networks, scientists of the Quantum Dynamics Division led by Professor...

Im Focus: Electromagnetic water cloak eliminates drag and wake

Detailed calculations show water cloaks are feasible with today's technology

Researchers have developed a water cloaking concept based on electromagnetic forces that could eliminate an object's wake, greatly reducing its drag while...

Im Focus: Scientists channel graphene to understand filtration and ion transport into cells

Tiny pores at a cell's entryway act as miniature bouncers, letting in some electrically charged atoms--ions--but blocking others. Operating as exquisitely sensitive filters, these "ion channels" play a critical role in biological functions such as muscle contraction and the firing of brain cells.

To rapidly transport the right ions through the cell membrane, the tiny channels rely on a complex interplay between the ions and surrounding molecules,...

Im Focus: Towards data storage at the single molecule level

The miniaturization of the current technology of storage media is hindered by fundamental limits of quantum mechanics. A new approach consists in using so-called spin-crossover molecules as the smallest possible storage unit. Similar to normal hard drives, these special molecules can save information via their magnetic state. A research team from Kiel University has now managed to successfully place a new class of spin-crossover molecules onto a surface and to improve the molecule’s storage capacity. The storage density of conventional hard drives could therefore theoretically be increased by more than one hundred fold. The study has been published in the scientific journal Nano Letters.

Over the past few years, the building blocks of storage media have gotten ever smaller. But further miniaturization of the current technology is hindered by...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

See, understand and experience the work of the future

11.12.2017 | Event News

Innovative strategies to tackle parasitic worms

08.12.2017 | Event News

AKL’18: The opportunities and challenges of digitalization in the laser industry

07.12.2017 | Event News

 
Latest News

Engineers program tiny robots to move, think like insects

15.12.2017 | Power and Electrical Engineering

One in 5 materials chemistry papers may be wrong, study suggests

15.12.2017 | Materials Sciences

New antbird species discovered in Peru by LSU ornithologists

15.12.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>