Patient recruitment target reached in pivotal trial of pemtumomab.(Antisoma PLC's Study of Monoclonal Antibody Radioimmunotherapy)

2002 NOV 7 - (NewsRx.com & NewsRx.net) -- Antisoma plc, a biopharmaceutical company based in Britain, announced it has reached the target for patient recruitment in its pivotal phase III study of pemtumomab in ovarian cancer.

Four hundred and twenty patients have been enrolled into the SMART (Study of Monoclonal Antibody Radioimmunotherapy) trial, which examines whether women with ovarian cancer who receive pemtumomab in addition to standard treatment survive longer than those receiving standard treatment alone.

Patient recruitment into SMART began in 1998, and a recent independent analysis showed that the trial is likely to be completed in the second half of 2004, with an interim analysis expected in approximately 12 months' time. The precise timing of the interim analysis and final results will depend on the overall death rate in the trial. If SMART confirms the survival benefit seen with pemtumomab in an earlier phase II trial, the study will form the basis of applications for marketing licenses.

Antisoma's lead product pemtumomab is designed for the treatment of intraabdominal cancer, with initial focus on ovarian and gastric cancers. A phase II study is ongoing in gastric cancer as well as the phase III study in ovarian cancer described above. The intended use in ovarian cancer is in patients in remission after surgery and chemotherapy. The drug targets remaining cancer ...