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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, Malm, 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
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Contact: Roana Mahmud
roana.mahmud@ketchum.com
44-207-611-3592
Ketchum
14-Nov-2002


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