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YM BioSciences Initiates Patient Enrolment In Phase II Colorectal Cancer Trial With EGFR Antibody

03 Aug 2007 - YM BioSciences Inc. announced that it has enrolled the first five patients within the 50-patient initial cohort of its Phase II trial with nimotuzumab in combination with irinotecan for the treatment of patients with colorectal cancer who have previously failed irinotecan-containing regimens. Recruitment of the first cohort is expected to be completed within approximately eight months, following which data on the primary endpoints, response rate and safety, will be reported.
 
The single-arm trial will enroll approximately 100 patients in Canada. The trial will enroll two 50-patient cohorts consecutively, with the first cohort receiving irinotecan on one of the conventional dosing schedules with weekly dosing of nimotuzumab and the second cohort receiving irinotecan on one of the conventional dosing schedules with nimotuzumab every two weeks. The first patient was enrolled into the study at the Southlake Regional Health Centre in Ontario under the principal investigator Dr. Labib Zibdawi. The study principal investigator is Dr. Amil Shah at the BC Cancer Agency in Vancouver. Fourteen sites across Canada are expected to participate in the trial of which two sites are currently open.
 
"We are very pleased with the enthusiasm of the investigators and the initial rate of enrollment, giving us confidence that data will be available within 12 months. Initiating this trial is another important milestone in our strategy to develop nimotuzumab on a global basis for a broad range of cancer indications," said David Allan, Chairman and CEO of YM BioSciences. "Results from this trial could further continue to confirm the unique safety profile of our EGFR-targeting antibody while establishing its efficacy, and expanding the prospective market for nimotuzumab into one of the largest cancer patient populations."
 
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). It continues to be differentiated from the other antibodies and small molecules targeting the tyrosine kinase pathway as treatment with the other drugs in this class may result in the debilitating and unpleasant side-effects of severe rash, conjunctivitis, painful paronychial inflammation, hypomagnesemia, diarrhea and constipation. Such side-effects have rarely been reported in patients treated with nimotuzumab.