ROCHE HALTS HEART TRANSPLANT TRIAL AFTER ACUTE REJECTION

Roche Laboratories, following discussion with the FDA, has terminated the Heart Spare The Nephron (STN) clinical trial due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from a calcineurin inhibitor (CNI) in combination with CellCept to Rapamune in combination with CellCept at 12 weeks after heart transplantation.

The safety and efficacy of CellCept (mycophenolate mofetil) in combination with Rapamune (sirolimus) following withdrawal of initial CNI therapy has not been established.

The Heart STN trial was an open-label, randomized, multicenter, multinational study. The trial was designed to investigate whether renal function benefit could be achieved with the withdrawal of CNI therapy followed by the introduction of sirolimus at 12 weeks after heart transplantation. Following heart transplantation, patients received the immunosuppressive therapy, including CellCept in combination with either cyclosporine or tacrolimus, and corticosteroids.

Of the seven patients randomized to the sirolimus, CellCept and corticosteroid arm, four experienced a grade IIIA rejection within five weeks of discontinuing CNI. No cases of graft loss occurred. There were no similar episodes of rejection in patients receiving the

calcineurin-based regimen (CNI, CellCept and corticosteroids).

There is limited data available from this study to draw a firm conclusion regarding the difference in the rejection rate between the two treatment arms, according to the company. Roche said it will continue to monitor the safety of CellCept through established reporting mechanisms and notify regulatory authorities of any serious adverse events for evaluation.

CellCept is currently indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.