EliTE-Symphony study recruitment begins

12 November 2002, Monte Carlo – Senior trial investigators today announced that the first person is about to be recruited into the EliTE* (Efficacy Limiting Toxicity Elimination)-Symphony Study, the largest renal transplantation trial ever to be conducted. Patient enrollment began this month and the study aims to recruit 1300 kidney transplant patients in total, from approximately 100 sites in 17 countries worldwide.

The objective of the EliTE-Symphony study will be to demonstrate that a combination of lower toxicity immunosuppressants CellCept® (mycophenolate mofetil, MMF), Zenapax® (daclizumab) and corticosteroids can enable a dose reduction of the higher toxicity immunosuppessants cyclosporine, tacrolimus or sirolimus, while simultaneously maintaining excellent efficacy. The results of this study will provide physicians with the opportunity to select an optimized immunosuppressive regimen.

Sponsor of the ELiTE-Symphony Study, Professor Henrik Ekberg, Lund University, Malmö, Sweden explained, "The focus in transplantation is now shifting. Although we are still concerned with reducing acute rejection, increasingly we are looking to develop long-term, low-toxicity treatment strategies which will result in patients retaining their transplanted organs for longer."

He continued, "With the EliTE-Symphony Study, we have the opportunity to evaluate established immunosuppressant treatment regimens that have never been compared before in such a way. We hope to show that CellCept® in combination with Zenapax® can allow for the safe reduction of combined therapies such as cyclosporine, tacrolimus or sirolimus to non-toxic levels with no loss in efficacy, and with improved long-term outcomes. It is the study which the transplant world has been waiting for and its results are likely to have a great impact on immunosuppressive regimen selection in the future."

The EliTE-Symphony Study is an independent investigator study fulfilling International Council on Harmonization (ICH) guideline requirements, sponsored by Professor Henrik Ekberg and Professor Philip F. Halloran, Edmonton, Canada and led by a steering committee of world renowned experts in the field of transplantation.

Notes to Editors:

The EliTE-Symphony Study is an open label study with 4 parallel arms:

Group A (control – standard immunosuppression)
MMF + normal dose cyclosporine + corticosteroids

Group B
daclizumab + MMF + low dose cyclosporine + corticosteroids

Group C
daclizumab + MMF + low dose tacrolimus + corticosteroids

Group D
daclizumab + MMF + low dose sirolimus + corticosteroids

The study will be open to either male or female single-organ renal transplant recipients (from living or cadaver donors), aged between 18 and 75 years.

Due to the scale of the study an automatic centralised randomisation system will be used to assign treatment arms to the patients. In addition, electronic data capture via the internet will be used to collect and to facilitate accurate patient reporting. These will ensure that ICH guidelines are followed.

Countries participating in the EliTE-Symphony Study include Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Germany, Greece, Israel, Italy, Mexico, Poland, Spain, Sweden, Turkey, UK, USA.

For further information please contact:
Roana Mahmud
Ketchum Healthcare, London
Office Tel: 44-207-611-3592
Email: roana.mahmud@ketchum.com

Sally Cresswell
Ketchum Healthcare, London
Office Tel: 44-207-611-3554
Email: sally.cresswell@ketchum.com

Monica Shuman
Ketchum Healthcare, London
Office Tel: 44-207-611-3645
Email: monica.shuman@ketchum.com

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