YM BioSciences' partner, Oncoscience AG, cleared for Phase III trial in Germany with nimotuzumaby
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.
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