Thymoglobulin: Phase II data; marketed to treat acute rejection of kidney transplants

In an international Phase II trial in 212 patients, 16 patients (15.9%) given Thymoglobulin had an acute rejection compared to 30 patients (28.3%) given Simulect basiliximab from Novartis AG (NVS; SWX:NOVN, Basel, Switzerland) at a mean follow-up of 9.6 months (p=0.03). In total, 19 patients (17.9%) given Thymoglobulin had acute rejection, graft loss or death, compared to 35 patients (33%) given Simulect (p=0.018). Both drugs had a similar safety profile. Results were presented at the 19th International Congress of the Transplantation Society meeting in Miami. In March, an independent Data Safety Monitoring Board (DSMB) recommended SANG stop the Phase II trial after the interim review showed significantly fewer acute rejections in patients taking Thymoglobulin (see BioCentury, March 25). SANG reported an earlier analysis representing a mean follow-up time of 6.9 months in April (see BioCentury, May 6). ...