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news.Canadian pharmaceutical company YM BioSciences has received clearance from Health Canada to start its phase II trial investigating nimotuzumab in patients with recurrent diffuse intrinsic pontine glioma, a form of childhood brain cancer.
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Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). The single-arm trial, which will enroll approximately 40 patients, will be initiated shortly in Canada. Subject to a positive review by the FDA, the trial will be extended into the US. The primary endpoint of this trial is response rate and recruitment is expected to be completed within approximately 18 months from initiation.
“Given that the median survival after recurrence for these patients is typically less than six months, nimotuzumab represents an opportunity to better serve this currently unmet medical need,” said David Allan, chairman and CEO of YM BioSciences.
“We remain optimistic that results will support the conclusion from previous trials: that our EGFR antibody has the potential to improve clinical outcomes with a superior safety profile compared to the other drugs in its class.”
Nimotuzumab is approved for sale in India and China as well as certain Latin American countries for the treatment of head and neck cancers.