Data from a study showed that certican (everolimus) is a novel, investigational immunosuppressant drug in its final stages of development. It has proved significantly more effective than azathioprine in preventing acute rejection and preserving pulmonary function in lung and heart / lung transplant patients.

Preventing acute rejection, and maintaining pulmonary function, is a major unmet medical need in lung transplantation. Described as a "proliferation inhibitor", Certican has been shown to target many of the underlying causes of chronic allograft dysfunction or late graft loss, including acute rejection and vascular remodelling.

In one of the largest global trials of its kind, over 200 patients from 33 centres in nine countries took part in the randomised, double-blind phase III study which is planned to last three years. Results at 12 months showed:

??22% of patients receiving Certican 1.5mg/bid reached the composite primary study endpoint (>15% decline in pulmonary function, graft loss or patient death) compared with 34% of patients receiving azathioprine (1.0 - 3.0 mg/kg/day) (p 0.0455)

??Certican was superior to azathioprine in terms of the number of acute rejection episodes requiring treatment (8% with Certican; 32% with azathioprine; p <0.001)

??Certican was superior to azathioprine in terms of the single endpoint of more than 15% reduced pulmonary function (16% of patients vs 28% respectively; p 0.034)

All patients received standard immunosuppressive therapy with full dose Neoral (cyclosporin for microemulsion) with or without corticosteroids.

Lead investigator, Associate Professor Gregory Snell commented: "Decline in pulmonary function is a common and problematic occurrence after lung transplantation. Principal causes include acute rejection and chronic allograft dysfunction, which manifests in lung transplant patients by obliteration and loss of the small bronchioles. There is an urgent need for immunosuppressive regimens with the capacity to address this complication and the impressive performance of Certican in this regard is very encouraging."

At the same meeting, 24 month results of adjunctive Certican versus azathioprine in a major international trial of over 600 heart transplant patients were presented. These data confirmed the superiority of Certican over azathioprine in terms of all-cause efficacy failure, acute rejection rates and cardiac allograft vasculopathy which is known to contribute to late graft loss or chronic allograft dysfunction.

It is conceivable that these attributes of Certican could have a major impact on both health-related quality of life for transplant patients and on medical care resource utilisation by decreasing morbidity, graft loss and the expense associated with prolonged hospitalisation and/or re-transplantation.