The phase I trial of AS1411 initially recruited patients with various cancers. During 2005, it was extended to recruit additional patients with renal and lung cancers.
The findings in renal cancer were particularly strong. Antisoma will, therefore, proceed to a phase II trial in this indication, the company said. Antisoma will also initiate a phase II trial in a blood cancer indication. Both trials are expected to start in 2007.
In the trial, 12 renal cancer patients were treated. All had advanced, metastatic disease and most had failed prior treatments. Nine showed clinical benefit, with seven having stable disease for two months or more, and two had objective responses.
Commenting on the phase I data, Professor Donald Miller, director of the Brown Cancer Center, said: “We’re very excited by the findings from this trial of AS1411, particularly the near complete absence of side effects and compelling signs of anti-tumor effects in renal cancer.”
“With this positive data behind us, we are ready for efficacy studies and intend to push AS1411 forward rapidly through parallel trials in renal and other cancers,” added Glyn Edwards, Antisoma’s CEO.
The results were presented at the European Society of Medical Oncology meeting in Istanbul.