Source: www.pharmaceutical-business-review.com
Author: staff

YM BioSciences, an oncology company, has announced that the National Cancer Centre of Singapore has selected nimotuzumab, the company’s EGFR-targeting drug, for evaluation in a multinational Phase III trial of more than 700 patients with cancers of the head and neck.

The National Cancer Centre of Singapore (NCCS) said that it selected nimotuzumab because of its reported preferential safety profile compared with other epidermal growth factor receptor (EGFR)-targeting cancer drugs. The trial is sponsored by the NCCS in collaboration with Innogene Kalbiotech, YM’s licensee for nimotuzumab for the region.

The NCCS is the lead cancer center coordinating this clinical trial, which will involve approximately 22 institutions from 12 countries worldwide. The trial will treat patients with locally advanced squamous cell cancers of the head and neck immediately following surgery – the ‘adjuvant setting’.

Along with standard chemotherapy and radiotherapy, half of the patients will be administered nimotuzumab weekly for an eight week period. The primary endpoint for this study is two-year and five-year disease-free survival; the secondary endpoint is two-year and five-year overall survival.

The countries involved in the trial include Japan, South Korea, Taiwan, Thailand, Indonesia, India, Pakistan, Singapore, Saudi Arabia, Israel, South Africa and Cuba. The trial is expected to expand into Canada and additional sites may also be added from the Philippines, Australia and the UK. The NCCS anticipates reporting initial results from the trial in approximately five years.

David Allan, chairman and CEO of YM BioSciences, said: “This trial further expands the number of late-stage trials investigating nimotuzumab across a wide range of cancer indications. In addition to this adjuvant Phase III study a Phase II investigator-initiated study in locally-advanced head and neck cancers is being conducted by the NCCS in collaboration with Innogene Kalbiotech.”