Clinical studies in brain cancer
Several clinical studies of the novel antisense drug trabedersen (AP 12009) for the treatment of high-grade or malignant glioma (the most aggressive form of primary central nervous system tumor) have already been completed. Before administration in humans, the safety of trabedersen was investigated in animal studies. Three Phase I/II studies were carried out in adult patients, in which an independent committee of experts rated trabedersen therapy as safe. A larger Phase IIb study with trabedersen confirmed the good safety profile and demonstrated very encouraging signs of efficacy compared to standard chemotherapy in high-grade glioma patients.
The ongoing SAPPHIRE Phase III study will assess the efficacy of trabedersen, its effect on quality of life during and after treatment, and its safety compared with standard chemotherapy, normally used in treating patients with recurrent or refractory anaplastic astrocytoma (a type of high-grade glioma).