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news.YM BioSciences's US subsidiary has been cleared by the FDA to initiate a Phase II trial investigating nimotuzumab in pediatric patients with inoperable brain cancer.
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Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (DIPG) and will be used in the trial to treat recurrent diffuse intrinsic pontine glioma. Eight leading US pediatric clinical centers will be participating in the study. YM BioSciences previously announced that it had received clearance from Health Canada in June 2007 to initiate this single-arm trial, which will enroll 44 patients with DIPG who will be treated with nimotuzumab as monotherapy.
YM BioSciences said that it believes that this is the first time in which a clinical trial has been cleared by the FDA for a drug of Cuban origin. Nimotuzumab has already been administered to a number of children in the US under licenses from the US Treasury Department and under single-patient INDs from the FDA.
The trial design is based on a previous trial conducted in Germany. In that trial, eight of 21 children with recurrent DIPG had a clinical benefit from treatment with nimotuzumab as monotherapy – one partial response (PR) and seven stable disease (SD) were reported in 21 patients, at the end of the induction phase at the eighth week. Those eight patients continued on maintenance therapy and, at week 21, three patients were declared PR and one was evaluated SD.