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Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function

Monday, June 2, 2008 General News J E 4
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TORONTO, June 1 The final results of the Spare the Nephron(STN) study, a multicenter trial investigating a novel kidney-sparingtreatment protocol using CellCept(R) (mycophenolate mofetil), showed theCellCept-based regimen in combination with sirolimus (SRL) is associated withimproved renal function when compared with the CellCept-based regimen incombination with calcineurin inhibitors (CNI).

Furthermore, the study showed this improvement without increasing the riskof acute rejection, and was tolerated in almost 80 percent of patients. Theresults were presented today at the American Transplant Congress (ATC) inToronto.

The STN Trial in kidney transplant recipients examines ways to preventrejection without damaging kidneys. As transplant patients are living longer,studies suggest that therapies such as CNIs can cause impairment of kidneyfunction, damage to the blood vessels, and filtering capacity of the kidneys."This study provides strong evidence for the benefits of a CNI-free,CellCept-based regimen," said Thomas Pearson, M.D., lead investigator,Livingston Professor of Surgery, Department of Surgery, Emory UniversitySchool of Medicine, Atlanta, GA.

The STN trials were conducted at more than 35 transplant centers in theUnited States and Canada.

"The goal of this study was to optimize the use of immunosuppressants forachieving long-term success," added Dr. Pearson. "The STN Kidney studied thecombination of CellCept and SRL with the goal of reducing CNI associatednephrotoxicity therapy to prolong graft and patient survival."

About the Study

This open-label, prospective, multicenter study, randomized 305 patients(maintained on MMF and a CNI) for 30-180 days post-transplant to receiveeither MMF (1-1.5 g BID) plus SRL (2-10 mg followed by at least 2 mg/day;trough 5-10 ng/mL) and discontinue the CNI (MMF/SRL) or to continue theircurrent regimen (MMF/CNI). Antibody induction and/or corticosteroids wereadministered according to individual center practices.

Study Results

The 12-month results are from the first 249 patients receiving either theCellCept-based regimen in combination with SRL (n=123) or the CellCept-basedregimen in combination with CNI (n=126).

Investigators found acute rejection in 6.5 percent of the patients (8/123)in the CellCept-based regimen in combination with SRL, compared to 7.1 percentof the patients (9/126) in the CellCept-based regimen in combination with CNI.

Mean time from transplant to randomization in both groups was 117 days.Baseline characteristics and measured GFR values were similar in the treatmentgroups and 98 patients in the CellCept-based regimen in combination with SRLwere receiving tacrolimus. Graft loss was experienced in 1.6 percent ofpatients (2/123) in the CellCept-based regimen in combination with SRL,compared to 2.4 percent of patients (3/126) in the CellCept-based regimen incombination with CNI.

There were no deaths in the CellCept-based regimen in combination with SRL.Three (3/126) patient deaths were remotely related to the CellCept-basedregimen in combination with CNI. The number and proportion of patientswithdrawn for adverse events at 12 months was 18.7 percent (23/123) in theCellCept-based regimen in combination with SRL, and 7.1 percent (9/126) in theCellCept-based regimen in combination with CNI.

The percent change from baseline in GFR at 12 months was 25.8 percent forpatients in the CellCept-based regimen in combination with SRL, compared to11.3 percent in the CellCept-based regimen in combination with CNI group.Safety outcomes were similar in both groups.

CellCept is indicated for the prophylaxis of organ rejection in patientsreceiving allogeneic renal, cardiac or hepatic transplants. CellCept shouldbe used concomitantly with cyclosporine and corticosteroids.

Important Safety Information:

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