YM BioSciences' partner, Oncoscience AG, cleared for Phase III trial in Germany with nimotuzumaby
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YM BioSciences Inc. announced that its partner, Oncoscience AG, has been cleared by the German regulatory authority for biological products, the Paul Ehrlich Institute, to initiate a Phase III trial of nimotuzumab in combination with radiation in children with inoperable pontine (brain stem) glioma. The clinical trial was also reviewed with the EMEA and is designed as a prospectively registrable study on the basis of a single arm trial because of the absence of treatment options for children suffering from pontine glioma. It is anticipated that marketing authorization subsequent to a successful trial would be sought under the EMEA centralized procedure.