Oncoscience enrolls Ph III nimotuzumab study

YM BioSciences, a Canadian oncology company, says that Oncoscience AG of Germany, its European partner for the development of the humanized EGFR-targeting monoclonal antibody, nimotuzumab, has recruited the 40th and final patient in its international Phase III trial combining nimotuzumab with radiation for the treatment of children and adolescents suffering from diffuse intrinsic pontine glioma. DIPG is an inoperable form of brain cancer for which treatment options are severely limited. The Phase III study is being conducted by an international group of pediatric oncologists under the lead of principal investigator Udo Bode, a professor at the University of Bonn, Germany. The primary end-point of the trial is progression-free survival with overall survival as a secondary endpoint. Nimotuzumab has been designated an Orphan Drug by the European Medicines Agency (EMEA).

"Oncoscience AG is moving to complete this DIPG trial, one in a series that, if successful, will be an important component of our nimotuzumab regulatory strategy," said David Allan, chief executive of YM BioSciences. "YM has received clearance for a Canadian Phase II trial in children with recurrent DIPG for which the principal investigatory site is the Hospital for Sick Children in Toronto, an internationally recognized center of excellence in pediatric medicine," he added.