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 3D images of cancer cells in the body: Medical physicists from Halle present new method
16.05.2018 | Martin-Luther-Universität Halle-Wittenberg

nachricht Better equipped in the fight against lung cancer
16.05.2018 | Friedrich-Alexander-Universität Erlangen-Nürnberg

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: LZH showcases laser material processing of tomorrow at the LASYS 2018

At the LASYS 2018, from June 5th to 7th, the Laser Zentrum Hannover e.V. (LZH) will be showcasing processes for the laser material processing of tomorrow in hall 4 at stand 4E75. With blown bomb shells the LZH will present first results of a research project on civil security.

At this year's LASYS, the LZH will exhibit light-based processes such as cutting, welding, ablation and structuring as well as additive manufacturing for...

Im Focus: Self-illuminating pixels for a new display generation

There are videos on the internet that can make one marvel at technology. For example, a smartphone is casually bent around the arm or a thin-film display is rolled in all directions and with almost every diameter. From the user's point of view, this looks fantastic. From a professional point of view, however, the question arises: Is that already possible?

At Display Week 2018, scientists from the Fraunhofer Institute for Applied Polymer Research IAP will be demonstrating today’s technological possibilities and...

Im Focus: Explanation for puzzling quantum oscillations has been found

So-called quantum many-body scars allow quantum systems to stay out of equilibrium much longer, explaining experiment | Study published in Nature Physics

Recently, researchers from Harvard and MIT succeeded in trapping a record 53 atoms and individually controlling their quantum state, realizing what is called a...

Im Focus: Dozens of binaries from Milky Way's globular clusters could be detectable by LISA

Next-generation gravitational wave detector in space will complement LIGO on Earth

The historic first detection of gravitational waves from colliding black holes far outside our galaxy opened a new window to understanding the universe. A...

Im Focus: Entangled atoms shine in unison

A team led by Austrian experimental physicist Rainer Blatt has succeeded in characterizing the quantum entanglement of two spatially separated atoms by observing their light emission. This fundamental demonstration could lead to the development of highly sensitive optical gradiometers for the precise measurement of the gravitational field or the earth's magnetic field.

The age of quantum technology has long been heralded. Decades of research into the quantum world have led to the development of methods that make it possible...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Save the date: Forum European Neuroscience – 07-11 July 2018 in Berlin, Germany

02.05.2018 | Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

 
Latest News

Research reveals how order first appears in liquid crystals

23.05.2018 | Life Sciences

Space-like gravity weakens biochemical signals in muscle formation

23.05.2018 | Life Sciences

NIST puts the optical microscope under the microscope to achieve atomic accuracy

23.05.2018 | Physics and Astronomy

VideoLinks
Science & Research
Overview of more VideoLinks >>>