The single-arm trial will enroll approximately 100 patients in Canada who will be treated with irinotecan plus nimotuzumab. Equal cohorts investigating two dosing schedules will be enrolled.
Recruitment of the first cohort is expected to be completed within approximately 12 months from initiation, following which data on the primary endpoint – response rate – will be reported.
“As colorectal cancer is the second leading cause of cancer death in North America, this trial could generate important data for expanding the prospective market for nimotuzumab,” said David Allan, chairman and CEO of YM BioSciences. “Other EGFR targeting antibodies have shown efficacy and been approved for treating this form of cancer. We are optimistic that this trial will give preliminary evidence that our EGFR antibody has the prospect for being as effective in response rates while providing a superior safety profile compared to other drugs in its class.”
Nimotuzumab is already approved for sale in India and China as well as certain Latin American countries for the treatment of head and neck cancers. YM BioSciences also intends to file for approval to conduct trials in pediatric pontine glioma, and esophageal cancer during 2007.