ROCHE STOPS CARDIAC DRUG TRIAL EARLY

Roche sent a letter notifying cardiac transplant healthcare practitioners that it brought an early halt to a clinical trial of its drug CellCept after four heart transplant patients suffered acute rejection.

The clinical trial was designed to investigate whether switching from calcineurin inhibitor therapy to sirolimus therapy could improve patients' renal function at the 12-week mark. Following heart transplantation, all patients received immunosuppressive therapy, including CellCept (mycophenolate mofetil) in combination with either cyclosporine or tacrolimus, and corticosteroids.

Of the seven patients who had been randomly assigned to the treatment arm of the trial, four experienced organ rejection within five weeks of discontinuing the calcineurin inhibitor therapy. Three of these patients responded well to treatment with corticosteroids and the fourth patient recovered after experiencing hemodynamic compromise, the company reported. None suffered graft loss. None of the eight patients in the control group, which continued receiving the calcineurin based regimen (calcineurin inhibitor, CellCept and corticosteroids) experienced rejections.

Roche said it has previously reported adverse events for CellCept at a greater than 30 percent incidence in the study population.

The letter can be accessed at www.fda.gov/medwatch/safety/2007/cellcept_DHCPletter_02-01-2007.pdf ( http://www.fda.gov/medwatch/safety/2007/cellcept_DHCPletter_02-01-2007.pdf ).